sodium sulfacetamide 9% sulfur 4% wash acella
 

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Sodium Sulfacetamide Sulfur Cleansing Pads


Generic Name: sulfacetamide sodium and sulfur swab
Dosage Form: swab
Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads In a vehicle containing Green Tea and Aloe Rx Only

DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent.
Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.
The structural formula is:


Each pad of Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are coated with a cleanser-based formulation. Each gram of this cleanser-based
formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: purified water, sodium cocoyl isethionate
disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate methyl paraben, propyl
paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl
taurate, white petrolatum.

CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact
that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption
through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in
the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of
acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are contraindicated for use by patients having known hypersensitivity
to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are not to be used by
patients with kidney disease.

WARNINGS: Although rare, sensitivity to sodium sulfacetaminde may occur. Therefore, caution and careful supervision should be observed when
prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute
hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should
be employed if areas of denuded or abraded skin are involved.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

PRECAUTIONS: General - If irritaition develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be
carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desqamation withour
irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of
acne vulfaris, but patients should be cautioned about the possibility.
Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive
irritation develops, discontinue use and consult your physician.

PREGNANCY: Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 4% Cleansing
Pads. It is not known whether Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads can cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% -
Sulfur 4% Cleansing Pads. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of
this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are
administered to a nursing woman.

PEDIATRIC USE: Safety and effectiveness in children under the age of 12 have not been established.

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION: Wash affected area(s) with cleansing pad once or twice dialy, or as directed by your physician. Wet area(s) with
water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry.
Discard pad. Do not flush.

HOW SUPPLIED: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are available in boxes of 60 cloths (3.7 g), (NDC 42192-113-60).
Store at controlled room temperature, 15° - 25° (59° - 77°F).
All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book
product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution
using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active
ingredients, incipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802

Sodum Sulfacetamide 10%-

Sulfur 4% Cleansing Pads


In a vehicle containing Green Tea and Aloe
Rx Only
60 cleansing pads
Net wegith 3.7g each
Acella pharmaceuticals
Directions: Wash affected areas with Sodium Sulfacetamide 10% - Sulfur 4% once or twice daily or as direted by your physician.
1. Wet affected areas with water
2. Wet Sodium Sulfacetamide 10% - Sulfur 4% cleansing pad with water and work into a full lather.
3. Cleanse face with Sodium Sulfacetamide 10% - Sulfur 4% for 10 -20 seconds, avoiding eyes
4. Rinse thoroughly and pat dry
5. Discard pad. Do not flush.
Warnings for external use only. Keep out of reach of children. Avoid contact with eyes.
Indications: for the typical control of acne vulgaris and seborrheic dermatitis. See package insert for full prescribing information.
Contraindications: Sodium Sulfacetamide 10% - Sulfur 4% cleansing pads are contraindicated for use in patients having known hypersensitivity to sulfonamides, sulfur or anyother component of the preparation. Sodium Sulfacetamide 10% - Sulfur 4% cleansing pads are not to be used by patients with kidney disease.
 
Contents: Sodium Sulfacetamide 10% - Sulfur 4%. Other Ingredients: purified water, sodium cocoyl isethionate, disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate methyl paraben, propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosufate, disodium EDTA, magnesium aluminum siliate, xanthan gum, sodium methyl cocoyl l-taurate, white petrolatum
Acella Pharmaceuticals
Store at 15 degrees to 25 degrees C or 59-77 degrees F)
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE. This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Please see package insert for more information.
Manufactured For:
Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802


SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS 
sodium sulfacetamide, sulfur  swab Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42192-113 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 10 g  in 100 g SULFUR (SULFUR) SULFUR 4 g  in 100 g Inactive Ingredients Ingredient Name Strength WATER   ALOE VERA LEAF   SODIUM THIOSULFATE   EDETATE DISODIUM   MAGNESIUM ALUMINUM SILICATE   XANTHAN GUM   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 42192-113-60 60 POUCH In 1 BOX contains a POUCH 1 3.7 g In 1 POUCH This package is contained within the BOX (42192-113-60)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/16/2010
Labeler - Acella Pharmaceuticals, LLC (825380939) Revised: 12/2010Acella Pharmaceuticals, LLC
More Sodium Sulfacetamide Sulfur Cleansing Pads resources Sodium Sulfacetamide Sulfur Cleansing Pads Side Effects (in more detail)Sodium Sulfacetamide Sulfur Cleansing Pads Use in Pregnancy & BreastfeedingSodium Sulfacetamide Sulfur Cleansing Pads Drug InteractionsSodium Sulfacetamide Sulfur Cleansing Pads Support Group18 Reviews for Sodium Sulfacetamide Sulfur Cleansings - Add your own review/rating Compare Sodium Sulfacetamide Sulfur Cleansing Pads with other medications AcneRosaceaSeborrheic Dermatitis
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Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit


Pronunciation: SOE-dee-um SUL-fa-SET-a-mide/SUL-fur in ue-REE-a
Generic Name: Sulfacetamide Sodium/Sulfur in Urea with Sunscreen
Brand Name: Rosula CLK
Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is used for:

Treating certain skin conditions (eg, acne vulgaris, acne rosacea, seborrheic dermatitis). It may also be used for other conditions as determined by your doctor.

Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is a kit containing a sulfonamide antibiotic/keratolytic combination along with sunscreen. The wash works by killing sensitive bacteria on the skin. It also helps to loosen and shed hard, scaly skin. The sunscreen helps to prevent sunburn.

Do NOT use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit if: you are allergic to any ingredient in Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit, to sulfur, or to sulfonamides (eg, sulfamethoxazole) you have kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit:

Some medical conditions may interact with Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have eczema if the skin at the application site is scraped, cut, or damaged.

Some MEDICINES MAY INTERACT with Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit. Because little, if any, of Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit:

Use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wet the skin and apply a generous amount of the wash to the affected area. Gently massage it into the skin for 10 to 20 seconds, working into a full lather. Rinse the skin well, and pat dry. Wash your hands immediately after using the medicine, unless your hands are part of the affected area. If your skin becomes dry, you may need to wash the medicine off a little sooner or use it less often. To use the sunscreen, apply a generous amount to areas that will be exposed to the sun. Reapply as needed, including after drying with a towel, swimming, and sweating. Use the wash on a regular schedule to get the most benefit from it. Continue to use it even if your condition improves. Do not miss any doses. If you miss a dose of the wash, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit.

Important safety information: Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is for external use only. Do not get it in your eyes or on the inside of your nose or mouth. If you get Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit in any of these areas, rinse right away with cool water. Talk with your doctor before you use any other medicines or cleansers on your skin. Do not apply Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit over large areas of the body or to open wounds or scraped, infected, or burned skin without first checking with your doctor. Do not use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit for other skin conditions at a later time. Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit may be harmful if swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit while you are pregnant. It is not known if Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is found in breast milk after topical use. If you are or will be breast-feeding while you use Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild redness or peeling; minor skin irritation

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or sore throat; purple or brownish spots on the skin; red, swollen, blistered, or peeling skin; severe or persistent skin irritation; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit:

Store Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Store away from heat and light. Keep Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit out of the reach of children and away from pets.

General information: If you have any questions about Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit, please talk with your doctor, pharmacist, or other health care provider. Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Kit. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Sulfacetamide Sodium/Sulfur in Urea with Sunscreen resources Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Use in Pregnancy & Breastfeeding Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Drug Interactions Sulfacetamide Sodium/Sulfur in Urea with Sunscreen Support Group 0 Reviews for Sulfacetamide Sodium/Sulfur in Urea with Sunscreen - Add your own review/rating Compare Sulfacetamide Sodium/Sulfur in Urea with Sunscreen with other medications Acne Rosacea Seborrheic Dermatitis
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SulZee Wash


Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)
Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is SulZee Wash (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about SulZee Wash (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to. What should I discuss with my healthcare provider before using SulZee Wash (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use SulZee Wash (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using SulZee Wash (sulfacetamide sodium and sulfur topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

SulZee Wash (sulfacetamide sodium and sulfur topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

new or worsening skin rash;

joint pain;

fever; or

mouth sores.

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect SulZee Wash (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More SulZee Wash resources SulZee Wash Use in Pregnancy & Breastfeeding SulZee Wash Drug Interactions 0 Reviews for SulZee - Add your own review/rating Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Prescribing Information (FDA) Plexion Prescribing Information (FDA) Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Prascion Cleanser Prescribing Information (FDA) Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Rosaderm Cleanser Prescribing Information (FDA) Rosanil Cleanser Prescribing Information (FDA) Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer) Rosula Prescribing Information (FDA) Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan Wash Prescribing Information (FDA) Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer) Sumaxin Wash Prescribing Information (FDA) Zencia Wash Prescribing Information (FDA) Compare SulZee Wash with other medications Acne Rosacea Seborrheic Dermatitis Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.
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Plexion Cleanser


Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)
Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is Plexion Cleanser (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Plexion Cleanser (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to. What should I discuss with my healthcare provider before using Plexion Cleanser (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Plexion Cleanser (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Plexion Cleanser (sulfacetamide sodium and sulfur topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

Plexion Cleanser (sulfacetamide sodium and sulfur topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

new or worsening skin rash;

joint pain;

fever; or

mouth sores.

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Plexion Cleanser (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Plexion Cleanser resources Plexion Cleanser Use in Pregnancy & BreastfeedingPlexion Cleanser Drug InteractionsPlexion Cleanser Support Group0 Reviews for Plexion - Add your own review/rating Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Prescribing Information (FDA) Plexion Prescribing Information (FDA) Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Prascion Cleanser Prescribing Information (FDA) Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Rosaderm Cleanser Prescribing Information (FDA) Rosanil Cleanser Prescribing Information (FDA) Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer) Rosula Prescribing Information (FDA) Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan Wash Prescribing Information (FDA) Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer) Sumaxin Wash Prescribing Information (FDA) Zencia Wash Prescribing Information (FDA) Compare Plexion Cleanser with other medications AcneRosaceaSeborrheic Dermatitis Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.
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Novacet


Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)
Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is Novacet (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Novacet (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to. What should I discuss with my healthcare provider before using Novacet (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Novacet (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Novacet (sulfacetamide sodium and sulfur topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

Novacet (sulfacetamide sodium and sulfur topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

new or worsening skin rash;

joint pain;

fever; or

mouth sores.

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Novacet (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Novacet resources Novacet Use in Pregnancy & BreastfeedingNovacet Drug InteractionsNovacet Support Group0 Reviews for Novacet - Add your own review/rating Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Prescribing Information (FDA) Plexion Prescribing Information (FDA) Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Prascion Cleanser Prescribing Information (FDA) Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Rosaderm Cleanser Prescribing Information (FDA) Rosanil Cleanser Prescribing Information (FDA) Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer) Rosula Prescribing Information (FDA) Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan Wash Prescribing Information (FDA) Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer) Sumaxin Wash Prescribing Information (FDA) Zencia Wash Prescribing Information (FDA) Compare Novacet with other medications AcneRosaceaSeborrheic Dermatitis Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.
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Avar-E Emollient


Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)
Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is Avar-E Emollient (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Avar-E Emollient (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to. What should I discuss with my healthcare provider before using Avar-E Emollient (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Avar-E Emollient (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Avar-E Emollient (sulfacetamide sodium and sulfur topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

Avar-E Emollient (sulfacetamide sodium and sulfur topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

new or worsening skin rash;

joint pain;

fever; or

mouth sores.

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Avar-E Emollient (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Avar-E Emollient resources Avar-E Emollient Use in Pregnancy & Breastfeeding Avar-E Emollient Drug Interactions Avar-E Emollient Support Group 0 Reviews for Avar-E Emollient - Add your own review/rating Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Prescribing Information (FDA) Plexion Prescribing Information (FDA) Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Prascion Cleanser Prescribing Information (FDA) Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Rosaderm Cleanser Prescribing Information (FDA) Rosanil Cleanser Prescribing Information (FDA) Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer) Rosula Prescribing Information (FDA) Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan Wash Prescribing Information (FDA) Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer) Sumaxin Wash Prescribing Information (FDA) Zencia Wash Prescribing Information (FDA) Compare Avar-E Emollient with other medications Acne Rosacea Seborrheic Dermatitis Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.
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Clarifoam EF


Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)
Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is Clarifoam EF (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Clarifoam EF (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to. What should I discuss with my healthcare provider before using Clarifoam EF (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Clarifoam EF (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Clarifoam EF (sulfacetamide sodium and sulfur topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

Clarifoam EF (sulfacetamide sodium and sulfur topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

new or worsening skin rash;

joint pain;

fever; or

mouth sores.

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Clarifoam EF (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Clarifoam EF resources Clarifoam EF Side Effects (in more detail) Clarifoam EF Use in Pregnancy & Breastfeeding Clarifoam EF Drug Interactions Clarifoam EF Support Group 8 Reviews for Clarifoam EF - Add your own review/rating Clarifoam EF Prescribing Information (FDA) Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer) Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer) Plexion Prescribing Information (FDA) Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Prascion Cleanser Prescribing Information (FDA) Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Rosaderm Cleanser Prescribing Information (FDA) Rosanil Cleanser Prescribing Information (FDA) Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer) Rosula Prescribing Information (FDA) Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan Wash Prescribing Information (FDA) Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer) Sumaxin Wash Prescribing Information (FDA) Zencia Wash Prescribing Information (FDA) Compare Clarifoam EF with other medications Acne Rosacea Seborrheic Dermatitis Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.

See also: Clarifoam EF side effects (in more detail)


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Avar-E Green


Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)
Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is Avar-E Green (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Avar-E Green (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to. What should I discuss with my healthcare provider before using Avar-E Green (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Avar-E Green (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Avar-E Green (sulfacetamide sodium and sulfur topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

Avar-E Green (sulfacetamide sodium and sulfur topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

new or worsening skin rash;

joint pain;

fever; or

mouth sores.

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Avar-E Green (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Avar-E Green resources Avar-E Green Use in Pregnancy & Breastfeeding Avar-E Green Drug Interactions Avar-E Green Support Group 0 Reviews for Avar-E Green - Add your own review/rating Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Prescribing Information (FDA) Plexion Prescribing Information (FDA) Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Prascion Cleanser Prescribing Information (FDA) Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Rosaderm Cleanser Prescribing Information (FDA) Rosanil Cleanser Prescribing Information (FDA) Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer) Rosula Prescribing Information (FDA) Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan Wash Prescribing Information (FDA) Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer) Sumaxin Wash Prescribing Information (FDA) Zencia Wash Prescribing Information (FDA) Compare Avar-E Green with other medications Acne Rosacea Seborrheic Dermatitis Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.
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Plexion Cleansing Cloths


Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)
Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is Plexion Cleansing Cloths (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Plexion Cleansing Cloths (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to. What should I discuss with my healthcare provider before using Plexion Cleansing Cloths (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Plexion Cleansing Cloths (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Plexion Cleansing Cloths (sulfacetamide sodium and sulfur topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

Plexion Cleansing Cloths (sulfacetamide sodium and sulfur topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

new or worsening skin rash;

joint pain;

fever; or

mouth sores.

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Plexion Cleansing Cloths (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Plexion Cleansing Cloths resources Plexion Cleansing Cloths Side Effects (in more detail) Plexion Cleansing Cloths Use in Pregnancy & Breastfeeding Plexion Cleansing Cloths Drug Interactions Plexion Cleansing Cloths Support Group 0 Reviews for Plexion - Add your own review/rating Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Prescribing Information (FDA) Plexion Prescribing Information (FDA) Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Prascion Cleanser Prescribing Information (FDA) Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Rosaderm Cleanser Prescribing Information (FDA) Rosanil Cleanser Prescribing Information (FDA) Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer) Rosula Prescribing Information (FDA) Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan Wash Prescribing Information (FDA) Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer) Sumaxin Wash Prescribing Information (FDA) Zencia Wash Prescribing Information (FDA) Compare Plexion Cleansing Cloths with other medications Acne Rosacea Seborrheic Dermatitis Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.

See also: Plexion side effects (in more detail)


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Sulfacetamide/Sulfur Emulsion


Pronunciation: sul-fa-SEE-ta-mide/SULL-fer
Generic Name: Sulfacetamide/Sulfur
Brand Name: Examples include Plexion TS and Sumaxin TS
Sulfacetamide/Sulfur Emulsion is used for:

Treating acne, rosacea, and seborrhea. It may also be used for other conditions as determined by your doctor.

Sulfacetamide/Sulfur Emulsion is a sulfonamide antibiotic and keratolytic. It works by killing bacteria and shedding the top layer of skin to help treat acne.

Do NOT use Sulfacetamide/Sulfur Emulsion if: you are allergic to any ingredient in Sulfacetamide/Sulfur Emulsion you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide you have kidney disease

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sulfacetamide/Sulfur Emulsion:

Some medical conditions may interact with Sulfacetamide/Sulfur Emulsion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have eczema or a history of lupus

Some MEDICINES MAY INTERACT with Sulfacetamide/Sulfur Emulsion. Tell your health care provider if you are taking any other medicines, especially any of the following:

Silver-containing products (eg, silver sulfadiazine) because they may decrease Sulfacetamide/Sulfur Emulsion's effectiveness Methenamine because it may increase the risk of Sulfacetamide/Sulfur Emulsion's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sulfacetamide/Sulfur Emulsion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sulfacetamide/Sulfur Emulsion:

Use Sulfacetamide/Sulfur Emulsion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Sulfacetamide/Sulfur Emulsion is for use on the skin only. Sulfacetamide/Sulfur Emulsion may stain clothing and the skin if too much is used. Wash hands before and after using Sulfacetamide/Sulfur Emulsion. Gently wash and dry the affected area. Apply a small amount of Sulfacetamide/Sulfur Emulsion to the affected area. Rub in gently. To clear up your infection completely, continue using Sulfacetamide/Sulfur Emulsion for the full course of treatment even if you feel better in a few days. Sulfacetamide/Sulfur Emulsion works best if it is used at the same time each day. Continue to use Sulfacetamide/Sulfur Emulsion even if you feel well. Do not miss any doses. If you miss a dose of Sulfacetamide/Sulfur Emulsion, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sulfacetamide/Sulfur Emulsion.

Important safety information: Avoid getting Sulfacetamide/Sulfur Emulsion in your eyes, nose, or mouth. If you get Sulfacetamide/Sulfur Emulsion in your eyes, rinse immediately with cool tap water. Talk with your doctor before you use any other medicines or cleansers on your skin. Do not apply Sulfacetamide/Sulfur Emulsion to open wounds or to damaged or burned skin without first checking with your doctor. If you use topical products too often, your condition may become worse. Sulfacetamide/Sulfur Emulsion only works against bacteria; it does not treat viral infections. Be sure to use Sulfacetamide/Sulfur Emulsion for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Sulfacetamide/Sulfur Emulsion may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Sulfacetamide/Sulfur Emulsion should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sulfacetamide/Sulfur Emulsion while you are pregnant. It is not known if Sulfacetamide/Sulfur Emulsion is found in breast milk after topical use. If you are or will be breast-feeding while you use Sulfacetamide/Sulfur Emulsion, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Sulfacetamide/Sulfur Emulsion:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild irritation, stinging, or burning of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cracked or extremely dry skin; fever; joint pain; red, swollen, scaling, or blistered skin; severe diarrhea; sores in the mouth; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Sulfacetamide/Sulfur side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Sulfacetamide/Sulfur Emulsion may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Sulfacetamide/Sulfur Emulsion:

Store Sulfacetamide/Sulfur Emulsion at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Sulfacetamide/Sulfur Emulsion out of the reach of children and away from pets.

General information: If you have any questions about Sulfacetamide/Sulfur Emulsion, please talk with your doctor, pharmacist, or other health care provider. Sulfacetamide/Sulfur Emulsion is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sulfacetamide/Sulfur Emulsion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Sulfacetamide/Sulfur resources Sulfacetamide/Sulfur Side Effects (in more detail) Sulfacetamide/Sulfur Use in Pregnancy & Breastfeeding Sulfacetamide/Sulfur Drug Interactions Sulfacetamide/Sulfur Support Group 18 Reviews for Sulfacetamide/Sulfur - Add your own review/rating Compare Sulfacetamide/Sulfur with other medications Acne Rosacea Seborrheic Dermatitis
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SE 10-5 SS Cream



Dosage Form: cream
SE 10-5 SS Cream
(sodium sulfacetamide 10% and sulfur 5%)

Rx Only

DESCRIPTION:

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Each gram of SE 10-5 SS (sodium sulfacetamide USP 10% and sulfur USP 5%) Cream contains: Active: Sodium Sulfacetamide 10% (100 mg) and Sulfur 5% (50 mg). Inactive: Benzyl Alcohol, Emulsifying Wax, Fragrance, Hamaelis virginiana (Witch Hazel) Distillate, Kaolin, Propanediol, Purified Water, Quillaja (Quillaia) saponaria Extract, Silicon Dioxide, Sodium Hydroxide, and Sodium Thiosulfate.

CLINICAL PHARMACOLOGY:

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS:

SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is not to be used by patients with kidney disease.

WARNINGS:

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

Sodium sulfacetamide contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section)."

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

PRECAUTIONS:

General – If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Information for Patients – Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility – Longterm studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy: Category C – Animal reproduction studies have not been conducted with SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream. It is also not known whether SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers – It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is administered to a nursing woman.

Pediatric Use – Safety and effectiveness in children under the age of 12 have not been established.

ADVERSE REACTIONS:

Although rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION:

Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.

HOW SUPPLIED:

SE 10-5 SS (sodium sulfacetamide 10% and sulfur 5%) Cream is available in a 4 oz. tube (NDC 13925-114-04).

Store at controlled room temperature 20° - 25°C (68° - 77° F).

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Rx Only

Manufactured For:

Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401

12/09

SETON PHARMACEUTICALS

PACKAGE LABEL- 113.4 g Tube Carton

NDC 13925-114-04        Rx Only

SE 10-5 SS Cream

(sodium sulfacetamide 10% and sulfur 5%)

4 oz. Cream

SETON PHARMACEUTICALS


SE 10-5 SS 
sodium sulfacetamide, sulfur  cream Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13925-114 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g SULFUR (SULFUR) SULFUR 50 mg  in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   WHITE WAX   WITCH HAZEL   KAOLIN   PROPANEDIOL   WATER   QUILLAJA SAPONARIA BARK   SILICON DIOXIDE   SODIUM HYDROXIDE   SODIUM THIOSULFATE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 13925-114-04 1 TUBE In 1 CARTON contains a TUBE 1 113.4 g In 1 TUBE This package is contained within the CARTON (13925-114-04)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/15/2010
Labeler - Seton Pharmaceuticals (828898002) Revised: 01/2012Seton Pharmaceuticals

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Sumaxin Cleansing Pads



Dosage Form: cloth
sumaxin®
(sodium sulfacetamide 10% & sulfur 4%)
Cleansing Pads

In a vehicle containing Green Tea & Aloe

Rx Only

Sumaxin Cleansing Pads Description

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Each pad of Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl stearate/PEG-100 stearate, green tea, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate, stearyl alcohol.

Sumaxin Cleansing Pads - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS

Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are not to be used by patients with kidney disease.

Warnings

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

Precautions General

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Information for Patients

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

PREGNANCY Category C

Animal reproduction studies have not been conducted with Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads. It is also not known whether Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in children under the age of 12 have not been established.

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation.

Sumaxin Cleansing Pads Dosage and Administration

Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.

How is Sumaxin Cleansing Pads Supplied

Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are available in boxes of 60 cloths (3.7 g), NDC 43538-100-60.

Store at 15°-30° C (59°-86° F).

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.

363 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com

IP001-R3
Rev. 6/11

PRINCIPAL DISPLAY PANEL - 60 Pad Carton

NDC 43538-100-60

Rx Only
sumaxin®
(sodium sulfacetamide 10% & sulfur 4%)
Cleansing Pads

In a vehicle containing Green Tea & Aloe

60 Cleansing Pads
Net wt. 3.7 g Each

MEDIMETRIKS
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 43538-101-60

Rx Only
sumaxin®
(Sodium Sulfacetamide 10%
& Sulfur 4%) Cleansing Pads
CP
KIT

CONTENTS:

1 - Sumaxin® (Sodium Sulfacemide 10% & Sulfur 4%)
Cleansing Pads Carton - 60 Pads (Net wt. 3.7 g each) 1 - Rehyla™ Wash Moisturizing Daily Wash (16 fl. oz.)

MEDIMETRIKS
PHARMACEUTICALS, INC.


SUMAXIN   CLEANSING PADS
sulfacetamide sodium and sulfur  cloth Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-100 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 g Sulfur (sulfur) Sulfur 40 mg  in 1 g Inactive Ingredients Ingredient Name Strength aloe   butylated hydroxytoluene   cetyl alcohol   disodium oleamido MEA-sulfosuccinate   edetate disodium   glycerin   green tea leaf   methylparaben   propylparaben   water   sodium cocoyl isethionate   sodium lauryl sulfoacetate   sodium thiosulfate   stearyl alcohol   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 43538-100-60 60 PACKET In 1 CARTON contains a PACKET 1 3.7 g In 1 PACKET This package is contained within the CARTON (43538-100-60)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2009
SUMAXIN CP 
sulfacetamide sodium and sulfur  kit Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-101 Packaging # NDC Package Description Multilevel Packaging 1 43538-101-60 1 KIT In 1 CARTON None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 60 PACKET   222 g Part 2 1 BOTTLE, PUMP   454 g Part 1 of 2 SUMAXIN   CLEANSING PADS
sulfacetamide sodium and sulfur  cloth Product Information       Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 g sulfur (sulfur) sulfur 40 mg  in 1 g Inactive Ingredients Ingredient Name Strength aloe   butylated hydroxytoluene   cetyl alcohol   disodium oleamido MEA-sulfosuccinate   edetate disodium   glycerin   green tea leaf   methylparaben   propylparaben   water   sodium cocoyl isethionate   sodium lauryl sulfoacetate   sodium thiosulfate   stearyl alcohol   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 60 PACKET In 1 CARTON contains a PACKET 1 3.7 g In 1 PACKET This package is contained within the CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2009
Part 2 of 2 REHYLA WASH 
inert  cream Product Information       Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength No Active Ingredients Found Inactive Ingredients Ingredient Name Strength water   glyceryl monostearate   glycerin   cetyl alcohol   disodium oleamido mipa-sulfosuccinate   cholesterol   disodium laureth sulfosuccinate   helianthus annuus seed wax   caprylyl glycol   propylene glycol   phenoxyethanol   sodium cocoyl isethionate   cocamidopropyl betaine   sodium methyl cocoyl taurate   C13-14 isoparaffin   sodium chloride   niacinamide   edetate disodium   hexylene glycol   laureth-7   chamaemelum nobile flower   hyaluronate sodium   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP 1 454 g In 1 BOTTLE, PUMP This package is contained within the CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 08/01/2011
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 08/01/2011
Labeler - Medimetriks Pharmaceuticals, Inc. (019903816) Establishment Name Address ID/FEI Operations IGI Laboratories 011036910 MANUFACTURE Revised: 12/2011Medimetriks Pharmaceuticals, Inc.
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sodium sulfacetamide and urea topical


Generic Name: sodium sulfacetamide and urea topical (SOW dee um sull fa SEH tah mide and yer EE ah)
Brand names: Carmol Scalp, Carmol Scalp Treatment Kit, Rosula NS

What is sodium sulfacetamide and urea topical?

Sodium sulfacetamide is an antibacterial agent. Sodium sulfacetamide interferes with the growth of bacteria on the skin.

Urea is an emollient (softening agent). It is used to moisturize the skin.

Sodium sulfacetamide and urea topical is used in the treatment of dandruff and seborrheic dermatitis (red, flaking skin rash).

Sodium sulfacetamide and urea topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about sodium sulfacetamide and urea topical? Stop using sodium sulfacetamide and urea topical and contact your healthcare provider if you develop new or worsening signs of skin irritation or a rash anywhere on the skin. Do not use other topical products on the scalp area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide and urea topical. Do not cover the area after applying sodium sulfacetamide and urea topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful. What should I discuss with my healthcare provider before using sodium sulfacetamide and urea topical? Do not use sodium sulfacetamide and urea topical without first talking to your doctor if you have an allergy to sulfa products. You may not be able to use sodium sulfacetamide and urea topical, or you may require special monitoring during treatment.

Do not apply sodium sulfacetamide and urea topical to large areas of open, broken, burned, or infected skin without first talking to your doctor. Large areas of damaged skin may allow more medicine to be absorbed by the body, possibly resulting in side effects.

Sodium sulfacetamide and urea topical is in the FDA pregnancy category C. This means that it is not known whether sodium sulfacetamide and urea topical will be harmful to an unborn baby. Do not use sodium sulfacetamide and urea topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether sodium sulfacetamide passes into breast milk. Do not use sodium sulfacetamide and urea topical without first talking to your doctor if you are breast-feeding a baby. How should I use sodium sulfacetamide and urea topical?

Use sodium sulfacetamide and urea topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash the hair before applying the medication, unless otherwise directed by your doctor. Part the hair one section at a time and apply a small quantity of lotion. Gently rub the lotion in with the fingertips to completely moisten the scalp. Brush the hair thoroughly for 2 to 3 minutes. For best results, the medication should be applied at bedtime and allowed to remain on the hair overnight unless otherwise directed by your doctor. The hair should be washed at least once a week. Rinsing with plain water or thorough brushing will remove any excess medication between washes.

Do not cover the affected area after applying sodium sulfacetamide and urea topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

It is important to use sodium sulfacetamide regularly to get the most benefit. It may take several weeks or more to see the effects of this drug.

Store sodium sulfacetamide and urea topical at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and apply only the next regularly scheduled dose.

What happens if I overdose?

An overdose of sodium sulfacetamide and urea topical is unlikely to threaten life. If an overdose is suspected or if the medication has been ingested, call a poison control center or an emergency room for advice.

What should I avoid while using sodium sulfacetamide and urea topical? Do not use other topical products on the scalp area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide and urea topical. Do not cover the area after applying sodium sulfacetamide and urea topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful. Sodium sulfacetamide and urea topical side effects Stop using sodium sulfacetamide and urea topical and contact your healthcare provider if you develop new or worsening signs of skin irritation or a rash anywhere on the skin. Serious side effects are not likely to occur with the use of sodium sulfacetamide and urea topical. If you experience a rare, but serious allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives), stop using sodium sulfacetamide and urea topical and seek emergency medical attention or contact your doctor immediately.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Sodium sulfacetamide and urea topical Dosing Information

Usual Adult Dose for Secondary Cutaneous Bacterial Infections:

Sodium sulfacetamide-urea 10%-10% topical lotion:
Apply to affected areas 2 to 4 times daily until cleared.
Sodium sulfacetamide-urea 10%-10% topical pads:
Apply to affected areas 1 to 2 times daily until cleared.

Usual Adult Dose for Dandruff:

Sodium sulfacetamide-urea 10%-10% topical lotion:
Apply to scalp at bedtime and leave on overnight. In severe cases, use twice daily.
Sodium sulfacetamide-urea 10%-10% topical pads:
Apply to affected areas 1 to 2 times daily.

Usual Adult Dose for Seborrheic Dermatitis:

Sodium sulfacetamide-urea 10%-10% topical lotion:
Apply to scalp at bedtime and leave on overnight. In severe cases, use twice daily.
Sodium sulfacetamide-urea 10%-10% topical pads:
Apply to affected areas 1 to 2 times daily.

Usual Pediatric Dose for Secondary Cutaneous Bacterial Infections:

Sodium sulfacetamide-urea 10%-10% topical lotion:
>=12 years:
Apply to affected areas 2 to 4 times daily until cleared.
Sodium sulfacetamide-urea 10%-10% topical pads:
>=12 years:
Apply to affected areas 1 to 2 times daily until cleared.

Usual Pediatric Dose for Dandruff:

Sodium sulfacetamide-urea 10%-10% topical lotion:
>=12 years:
Apply to scalp at bedtime and leave on overnight. In severe cases, use twice daily.
Sodium sulfacetamide-urea 10%-10% topical pads:
>=12 years:
Apply to affected areas 1 to 2 times daily.

Usual Pediatric Dose for Seborrheic Dermatitis:

Sodium sulfacetamide-urea 10%-10% topical lotion:
>=12 years:
Apply to scalp at bedtime and leave on overnight. In severe cases, use twice daily.
Sodium sulfacetamide-urea 10%-10% topical pads:
>=12 years:
Apply to affected areas 1 to 2 times daily.

What other drugs will affect sodium sulfacetamide and urea topical? Do not use other topical products on the scalp area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide and urea topical.

Drugs other than those listed here may also interact with sodium sulfacetamide and urea topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More sodium sulfacetamide and urea topical resources Sodium sulfacetamide and urea topical Use in Pregnancy & Breastfeeding Sodium sulfacetamide and urea topical Support Group 0 Reviews for Sodium sulfacetamide and urea - Add your own review/rating Compare sodium sulfacetamide and urea topical with other medications Dandruff Seborrheic Dermatitis Secondary Cutaneous Bacterial Infections Where can I get more information? Your pharmacist has additional information about sodium sulfacetamide and urea topical written for health professionals that you may read.
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Sulfatol C Cream


sulfacetamide sodium and sulfur
Dosage Form: cream
Sulfatol C™ Cream

Rx Only

PRODUCT DESCRIPTION

Sulfatol C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is available by prescription only and contains the following active ingredients: Sulfacetamide Sodium 10% and Sulfur 5%.

Chemically, sulfacetamide sodium is Acetamide, N-[(4-aminophenyl) sulfonyl], monosodium salt, monohydrate. The structural formula is:

INACTIVE INGREDIENTS: Benzyl Alcohol, Cetyl Alcohol, Cocoglycerides, Dimethicone, Disodium EDTA, Fragrance, Glyceryl and PEG-100 Stearate, Isopropyl Myristate, Light Mineral Oil, Polysorbate 60, Propylene Glycol, Sodium Thiosulfate, Sorbitan Monostearate, Stearyl Alcohol, Urea, Purified Water, Xanthan Gum, Zinc Ricinoleate.

Sulfatol C Cream - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS

Sulfatol C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sulfatol C™ Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfatol C™ Cream is not to be used by patients with kidney disease.

FOR EXTERNAL USE ONLY. Keep out of reach of children. Keep away from eyes. Keep tube tightly closed.

Warnings

Although rare, sensitivity to sulfacetamide sodium may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

Precautions General

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sulfacetamide sodium and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris but patients should be cautioned about the possibility.

Information for Patients

Sulfatol C™ Cream is intended for external use only. Avoid contact with eyes, eyelids, lips, other mucous membranes (e.g., inside the nose), and any damaged areas of the skin, such as wounds or open sores. If accidental contact with one of these areas occurs, rinse thoroughly with water.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy Category C

Animal reproduction studies have not been conducted with Sulfatol C™ Cream. It also is not known whether Sulfatol C™ Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfatol C™ Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether sulfacetamide sodium is excreted in human milk following topical use of Sulfatol C™ Cream. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfatol C™ Cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under 12 years of age has not been established.

Possible Side Effects

Like any medication, Sulfatol C™ Cream may occasionally cause side effects in some people. Although uncommon, some possible side effects may include skin irritation such as redness, dryness, itching or swelling. If you experience excessive skin irritation, contact your physician.

Directions For Use

Apply Sulfatol C™ Cream to affected area(s) 1-3 times daily, or as directed by your physician.

1) Cleanse your skin thoroughly before application. 2) Apply a thin layer of Sulfatol C™ Cream to the affected area(s) as directed by your physician 3) Start by using Sulfatol C™ Cream once daily to minimize dryness.

Then, increase application frequency to 2-3 times daily or as directed by your physician.

How is Sulfatol C Cream Supplied

Sulfatol C™ Cream (sulfacetamide sodium 10% and sulfur 5%) is available in 1 oz. tubes. (NDC 51991-559-41)

Storage

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in original container.

Warning

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Groupe Parima Inc., Montr?al, QC Canada H4S 1X6

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Iss: 9/08

PRINCIPAL DISPLAY PANEL - 28g tube carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-559-41

Sulfatol C™ Cream
Sulfacetamide Sodium 10% and Sulfur 5%

Rx Only
Net Wt. 1 oz. (28g)

Skin Cream
For The Topical Control Of

Acne Vulgaris Acne Rosacea Seborrheic Dermatitis
SULFATOL C 
sulfacetamide sodium and sulfur  cream Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-559 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (Sulfacetamide) Sulfacetamide Sodium 2.8 g  in 28 g Sulfur (Sulfur) Sulfur 1.4 g  in 28 g Inactive Ingredients Ingredient Name Strength Benzyl Alcohol   Cetyl Alcohol   Coco-glycerides   Dimethicone   Edetate Disodium   Glycerin   Polyoxyl 100 Stearate   Isopropyl Myristate   Light Mineral Oil   Polysorbate 60   Propylene Glycol   Sodium Thiosulfate   Sorbitan Monostearate   Stearyl Alcohol   Urea   Water   Xanthan Gum   Product Characteristics Color YELLOW (light-yellow) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 51991-559-41 1 TUBE In 1 BOX contains a TUBE 1 28 g In 1 TUBE This package is contained within the BOX (51991-559-41)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/01/2009 09/30/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335) Establishment Name Address ID/FEI Operations Groupe Parima 252437850 MANUFACTURE Revised: 05/2010Breckenridge Pharmaceutical, Inc.
More Sulfatol C Cream resources Sulfatol C Cream Side Effects (in more detail)Sulfatol C Cream Use in Pregnancy & BreastfeedingSulfatol C Cream Drug Interactions0 Reviews for Sulfatol C - Add your own review/rating Compare Sulfatol C Cream with other medications AcneRosaceaSeborrheic Dermatitis
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Carmol Scalp Treatment Kit


Generic Name: sulfacetamide sodium and urea topical (sul fa SEET a mide SOE dee um and ure EE a TOP i kal)
Brand Names: Carmol Scalp, Carmol Scalp Treatment Kit, Rosula NS

What is Carmol Scalp Treatment Kit (sulfacetamide sodium and urea topical)?

Sulfacetamide sodium is a sulfa antibiotic that fights bacteria on the skin.

Urea helps moisturize the skin.

The combination of sulfacetamide sodium and urea topical (for the skin) is used to treat acne vulgaris and seborrheic dermatitis (red, flaking skin rash).

Sulfacetamide sodium and urea topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Carmol Scalp Treatment Kit (sulfacetamide sodium and urea topical)? You should not use this medication if you are allergic to sulfacetamide, urea, or sulfa drugs. Do not use sulfacetamide sodium and urea topical medicated pads if you have kidney disease.

To make sure you can safely use sulfacetamide sodium and urea topical, tell your doctor if you have a history of burns, open sores, or skin wounds in the skin area you plan to treat with this medication.

Do not use sulfacetamide sodium and urea topical to treat any skin condition that has not been checked by your doctor.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve, or if they get worse while using sulfacetamide sodium and urea topical.

Do not share this medication with another person, even if they have the same symptoms you have. What should I discuss with my healthcare provider before using Carmol Scalp Treatment Kit (sulfacetamide sodium and urea topical)? You should not use this medication if you are allergic to sulfacetamide, urea, or sulfa drugs. Do not use sulfacetamide sodium and urea topical medicated pads if you have kidney disease.

To make sure you can safely use sulfacetamide sodium and urea topical, tell your doctor if you have a history of burns, open sores, or skin wounds in the skin area you plan to treat with this medication.

Do not use sulfacetamide sodium and urea topical to treat any skin condition that has not been checked by your doctor. FDA pregnancy category C. It is not known whether sulfacetamide sodium and urea topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and urea topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Carmol Scalp Treatment Kit (sulfacetamide sodium and urea topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication is usually applied 1 to 3 times per day. Follow your doctor's instructions.

Wash your hands after applying the lotion or using the medicated pad.

Do not cover the treated skin area unless your doctor has told you to.

Throw away the medicated pad after one use.

Use sulfacetamide sodium and urea topical regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve, or if they get worse while using sulfacetamide sodium and urea topical.

Do not share this medication with another person, even if they have the same symptoms you have.

This medicine may appear to get darker in color over time. This is not harmful and will not affect safe use of sulfacetamide sodium and urea topical.

Store at room temperature away from moisture and heat. Do not freeze. What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Carmol Scalp Treatment Kit (sulfacetamide sodium and urea topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not apply the medication to your lips or eyelids. Do not use sulfacetamide sodium and urea topical on irritated or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and urea topical unless you doctor tells you to.

Carmol Scalp Treatment Kit (sulfacetamide sodium and urea topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using sulfacetamide sodium and urea topical and call your doctor at once if you have a serious side effect such as:

fever, sore throat, body aches, flu symptoms;

mouth sores;

easy bruising or bleeding, unusual weakness;

dark urine, jaundice (yellowing of the skin or eyes); or

warmth, swelling, oozing, or other signs of skin infection; or

severe burning, stinging, swelling, or redness of your skin after applying this medicine.

Less serious side effects may include mild skin irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Carmol Scalp Treatment Kit (sulfacetamide sodium and urea topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and urea topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Carmol Scalp Treatment Kit resources Carmol Scalp Treatment Kit Side Effects (in more detail) Carmol Scalp Treatment Kit Use in Pregnancy & Breastfeeding 0 Reviews for Carmol Scalp Treatment - Add your own review/rating Rosula NS Medicated Pads MedFacts Consumer Leaflet (Wolters Kluwer) Compare Carmol Scalp Treatment Kit with other medications Dandruff Seborrheic Dermatitis Secondary Cutaneous Bacterial Infections Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and urea topical.

See also: Carmol Scalp Treatment side effects (in more detail)


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Sulfatol SS Cream


sulfacetamide sodium and sulfur
Dosage Form: cream
Sulfatol SS™ Cream with Sunscreens

Rx Only

PRODUCT DESCRIPTION

Each gram of Sulfatol SS Cream with Sunscreens contains 100 mg of sodium sulfacetamide and 50 mg of sulfur. Sulfacetamide sodium is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent sulfur.

Chemically, sulfacetamide sodium is Acetamide, N-[(4-aminophenyl) sulfonyl], monosodium salt, monohydrate. The structural formula is:

INACTIVE INGREDIENTS

Avobenzone USP, Benzyl Alcohol NF, Cetyl Alcohol NF, Cocoglycerides, Dimethicone 200/100, Edetate Disodium USP, Fragrance, Glyceryl Stearate/PEG-100 Stearate, Isopropyl Myristate NF, Light Mineral Oil NF, Octinoxate USP, Polysorbate 60 NF, Propylene Glycol USP, Purified Water USP, Sodium Thiosulfate USP, Sorbitan Monostearate NF, Stearyl Alcohol NF, Xanthan Gum NF.

Sulfatol SS Cream - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS

Sulfatol SS™ Cream with Sunscreens is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

Sulfatol SS™ Cream with Sunscreens is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. This product should not to be used by patients with kidney disease.

FOR EXTERNAL USE ONLY. Keep out of reach of children. Keep away from eyes. Keep away from mucous membranes. Keep tube tightly closed.

Warnings

Although rare, fatalities have occurred due to severe reactions to sulfonamides, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this medication (see ADVERSE REACTIONS section).

Sulfacetamide sodium contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).

Precautions General

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause erythema (redness) and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy Category C

Animal reproduction studies have not been conducted with sulfacetamide sodium. It is also not known whether sulfacetamide sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium should be given to a pregnant woman only if clearly needed. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well-controlled studies of sulfacetamide sodium in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers

It is not known whether sulfacetamide sodium is excreted in human milk following topical use of sulfacetamide sodium. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use

Safety and effectiveness in children under 12 years of age has not been established.

Adverse Reactions

Although rare, sulfacetamide sodium may cause local irritation, including stinging and burning. Other adverse events associated with the use of sulfacetamide sodium are as follows: Erythema (redness), itching and edema.

Directions

Cleanse affected areas. Apply a thin film 1 to 3 times daily, or as directed by a physician.

How is Sulfatol SS Cream Supplied

Sulfatol SS™ Cream with Sunscreens (sulfacetamide sodium 10% and sulfur 5%) is supplied in 45 g tubes. NDC 51991-302-45

Storage

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in original container.

Warning

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Groupe Parima Inc., Montr?al, QC Canada H4S 1X6

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Iss: 2/09

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-302-45

Sulfatol SS™ Cream with Sunscreens
Sulfacetamide Sodium 10% and Sulfur 5%

Rx Only
Net Wt. 45 g

For The Topical Control Of

Acne Vulgaris Acne Rosacea Seborrheic Dermatitis
SULFATOL SS 
sulfacetamide sodium and sulfur  cream Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-302 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfacetamide Sodium (Sulfacetamide) Sulfacetamide Sodium 100 mg  in 1 g Sulfur (Sulfur) Sulfur 50 mg  in 1 g Inactive Ingredients Ingredient Name Strength Avobenzone   Benzyl Alcohol   Cetyl Alcohol   Coco-glycerides   Dimethicone   Edetate Disodium   Glyceryl Monostearate   Polyoxyl 100 Stearate   Isopropyl Myristate   Light Mineral Oil   Octinoxate   Polysorbate 60   Propylene Glycol   Water   Sodium Thiosulfate   Sorbitan Monostearate   Stearyl Alcohol   Xanthan Gum   Product Characteristics Color YELLOW (light-yellow) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 51991-302-45 1 TUBE In 1 BOX contains a TUBE 1 45 g In 1 TUBE This package is contained within the BOX (51991-302-45)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 08/01/2009 02/28/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335) Establishment Name Address ID/FEI Operations Groupe Parima 252437850 MANUFACTURE Revised: 05/2010Breckenridge Pharmaceutical, Inc. More Sulfatol SS Cream resources Sulfatol SS Cream Side Effects (in more detail) Sulfatol SS Cream Use in Pregnancy & Breastfeeding Sulfatol SS Cream Drug Interactions 0 Reviews for Sulfatol SS - Add your own review/rating Compare Sulfatol SS Cream with other medications Acne Rosacea Seborrheic Dermatitis
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Vasosulf


Generic Name: sulfacetamide and phenylephrine ophthalmic (sul fa SET a mide/ fen ill EFF rin)
Brand Names: Vasosulf

What is Vasosulf (sulfacetamide and phenylephrine ophthalmic)?

Sulfacetamide is an antibiotic. It is used to treat bacterial infections.

Phenylephrine is a vasoconstrictor. It makes the blood vessels in your eyes smaller to reduce redness and congestion, and to keep the sulfacetamide in your eye for a longer period of time.

Sulfacetamide and phenylephrine ophthalmic is used to treat bacterial infections of the eyes.

Sulfacetamide and phenylephrine ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Vasosulf (sulfacetamide and phenylephrine ophthalmic)?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

Who should not use Vasosulf (sulfacetamide and phenylephrine ophthalmic)? Do not use sulfacetamide and phenylephrine ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

Do not use sulfacetamide and phenylephrine ophthalmic if you have ever had an allergic reaction to a "sulfa"-based drug.

It is not known whether sulfacetamide and phenylephrine ophthalmic will harm an unborn baby. Do not use sulfacetamide and phenylephreine ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether sulfacetamide and phenylephrine ophthalmic passes into breast milk. Do not use sulfacetamide and phenylephreine ophthalmic without first talking to your doctor if you are breast-feeding a baby. How should I use Vasosulf (sulfacetamide and phenylephrine ophthalmic)?

Use sulfacetamide and phenylephrine ophthalmic eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops.

To apply the eyedrops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store sulfacetamide and phenylephrine ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using Vasosulf (sulfacetamide and phenylephrine ophthalmic)? Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Sulfacetamide and phenylephrine ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Vasosulf (sulfacetamide and phenylephrine ophthalmic) side effects

Serious side effects are not expected with this medication.

Commonly, some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur. Continue to use sulfacetamide and phenylephrine ophthalmic and talk to your doctor about any side effects you experience.

What other drugs will affect Vasosulf (sulfacetamide and phenylephrine ophthalmic)?

Do not use this medication with other eye drops containing nitrates (e.g., silver nitrate).

Avoid using other eyedrops or medications unless they are approved by your doctor.

Drugs other than those listed here may also interact with sulfacetamide and phenylephrine ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Vasosulf resources Vasosulf Drug Interactions Vasosulf Support Group 0 Reviews for Vasosulf - Add your own review/rating Compare Vasosulf with other medications Conjunctivitis, Bacterial Eye Dryness/Redness Where can I get more information? Your pharmacist has additional information about sulfacetamide and phenylephrine ophthalmic written for health professionals that you may read. What does my medication look like?

Sulfacetamide and phenylephrine ophthalmic is available with a prescription under the brand name Vasosulf in a 15% solution. Other brand and generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


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Cetamide


Generic Name: sulfacetamide ophthalmic (SUL fa SEET a mide off THAL mik)
Brand Names: Bleph-10, Ocu-Sul 10, Ocu-Sul 15, Ocu-Sul 30, Sodium Sulamyd, Sulf-10, Sulfac 10%

What is Cetamide (sulfacetamide ophthalmic)?

Sulfacetamide ophthalmic is an antibiotic.

Sulfacetamide ophthalmic is used to treat bacterial infections of the eyes.

Sulfacetamide ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Cetamide (sulfacetamide ophthalmic)? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

Who should not use Cetamide (sulfacetamide ophthalmic)? Do not use sulfacetamide ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

Do not use sulfacetamide ophthalmic if you have ever had an allergic reaction to a sulfa-based drug.

It is not known whether sulfacetamide ophthalmic will harm an unborn baby. Do not use sulfacetamide ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether sulfacetamide ophthalmic passes into breast milk. Do not use sulfacetamide ophthalmic without first talking to your doctor if you are breast-feeding a baby. How should I use Cetamide (sulfacetamide ophthalmic)?

Use sulfacetamide ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eye drops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

To apply the ointment:

Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before the next application.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store sulfacetamide ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using Cetamide (sulfacetamide ophthalmic)? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Sulfacetamide ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with sulfacetamide ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with sulfacetamide ophthalmic unless otherwise directed by your doctor. Cetamide (sulfacetamide ophthalmic) side effects

Serious side effects are not expected with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cetamide (sulfacetamide ophthalmic)?

Do not use this medication with other eyedrops containing nitrates (e.g., silver nitrate).

Do not use other eye drops or medications during treatment with sulfacetamide ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with sulfacetamide ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Cetamide resources Cetamide Side Effects (in more detail)Cetamide Use in Pregnancy & BreastfeedingCetamide Drug InteractionsCetamide Support Group0 Reviews for Cetamide - Add your own review/rating Bleph-10 Drops MedFacts Consumer Leaflet (Wolters Kluwer) Bleph-10 Prescribing Information (FDA) Isopto Cetamide Prescribing Information (FDA) Compare Cetamide with other medications ConjunctivitisTrachoma Where can I get more information? Your pharmacist has additional information about sulfacetamide ophthalmic written for health professionals that you may read.

See also: Cetamide side effects (in more detail)


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sulfur topical


Generic Name: sulfur topical (SULL fur)
Brand Names: Acnotex, Fostril, Liquimat Light, Liquimat Medium, Rezamid, Sulfo-Lo, Sulfoam, Sulforcin, Sulmasque, Sulpho-Lac, Sulpho-Lac Soap

What is sulfur topical?

Topical sulfur causes drying and peeling of the skin. This allows excess oil and dirt to be easily washed away.

Sulfur topical is used to treat acne.

Sulfur topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about sulfur topical?

Do not use sulfur on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid abrasive, harsh, or drying soaps and cleansers while using sulfur topical.

Who should not use sulfur topical? Do not use sulfur topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions much worse. Also avoid using sulfur topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not use sulfur topical during treatment with other topical acne products unless otherwise directed with your doctor. The combination could lead to severe skin irritation.

It is not known whether sulfur topical will harm an unborn baby. Do not use sulfur topical without first talking to your doctor if you are pregnant. It is also not known whether sulfur passes into breast milk. Do not use sulfur topical without first talking to your doctor if you are breast-feeding a baby. How should I use sulfur topical?

Use sulfur topical exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying this medication.

Shake lotions well before using them. Clean and dry the area to which you will apply sulfur topical. Apply the medication to the affected area. When applying sulfur topical, avoid your eyes, the inside of your nose and mouth, your lips, and areas where the skin is broken to prevent excessive irritation. If you get medication in any of these areas, rinse it off with water.

Do not cover the affected area after applying sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Sulfur topical is usually applied one to three times daily.

It may take several weeks or more to see the effects of this drug. Do not stop using sulfur topical if you do not see results immediately.

Apply sulfur topical less often if you experience excessive burning, dryness, or irritation.

Store sulfur topical at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.

What happens if I overdose?

An overdose of sulfur topical is unlikely to occur. If you do suspect an overdose, or if sulfur topical has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using sulfur topical? Do not use sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid using other topical products on the same area unless otherwise directed to do so by your doctor. They may interfere with the effects or absorption of sulfur topical.

Do not cover the area after applying sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Avoid using harsh, abrasive or irritating cleansers, perfumes or cosmetics on the area you are treating.

Sulfur topical side effects Serious side effects are not likely to occur. Stop using sulfur topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some burning, stinging, tingling, itching, redness, dryness, peeling, or irritation while you are using sulfur topical. If these side effects are excessive, apply sulfur topical less often.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Sulfur topical Dosing Information

Usual Adult Dose for Acne:

Cream and bar form:
Use on the skin as needed.
Lotion form:
Use on the skin two or three times a day.

Usual Pediatric Dose for Acne:

Cream and bar form:
Use on the skin as needed.
Lotion form:
Use on the skin two or three times a day.

What other drugs will affect sulfur topical?

Do not use other topical preparations unless directed to do so by your doctor. They may interfere with your treatment or increase irritation to your skin.

Avoid using harsh, abrasive or irritating cleansers, perfumes, or cosmetics on the area you are treating.

Drugs other than those listed here may also interact with sulfur topical. Talk to your doctor and pharmacist before taking any prescription or over the counter medicines.

More sulfur topical resources Sulfur topical Side Effects (in more detail) Sulfur topical Dosage Sulfur topical Use in Pregnancy & Breastfeeding Sulfur topical Drug Interactions Sulfur topical Support Group 1 Review for Sulfur - Add your own review/rating Sulfo-Lo Topical Advanced Consumer (Micromedex) - Includes Dosage Information Compare sulfur topical with other medications Acne Where can I get more information? Your pharmacist has additional information about sulfur topical written for health professionals that you may read.

See also: sulfur side effects (in more detail)


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Isopto Cetamide


Generic Name: sulfacetamide ophthalmic (SUL fa SEET a mide off THAL mik)
Brand Names: Bleph-10, Ocu-Sul 10, Ocu-Sul 15, Ocu-Sul 30, Sodium Sulamyd, Sulf-10, Sulfac 10%

What is Isopto Cetamide (sulfacetamide ophthalmic)?

Sulfacetamide ophthalmic is an antibiotic.

Sulfacetamide ophthalmic is used to treat bacterial infections of the eyes.

Sulfacetamide ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Isopto Cetamide (sulfacetamide ophthalmic)? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

Who should not use Isopto Cetamide (sulfacetamide ophthalmic)? Do not use sulfacetamide ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

Do not use sulfacetamide ophthalmic if you have ever had an allergic reaction to a sulfa-based drug.

It is not known whether sulfacetamide ophthalmic will harm an unborn baby. Do not use sulfacetamide ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether sulfacetamide ophthalmic passes into breast milk. Do not use sulfacetamide ophthalmic without first talking to your doctor if you are breast-feeding a baby. How should I use Isopto Cetamide (sulfacetamide ophthalmic)?

Use sulfacetamide ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eye drops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

To apply the ointment:

Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before the next application.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store sulfacetamide ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using Isopto Cetamide (sulfacetamide ophthalmic)? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Sulfacetamide ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with sulfacetamide ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with sulfacetamide ophthalmic unless otherwise directed by your doctor. Isopto Cetamide (sulfacetamide ophthalmic) side effects

Serious side effects are not expected with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Isopto Cetamide (sulfacetamide ophthalmic)?

Do not use this medication with other eyedrops containing nitrates (e.g., silver nitrate).

Do not use other eye drops or medications during treatment with sulfacetamide ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with sulfacetamide ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Isopto Cetamide resources Isopto Cetamide Side Effects (in more detail) Isopto Cetamide Use in Pregnancy & Breastfeeding Isopto Cetamide Drug Interactions Isopto Cetamide Support Group 0 Reviews for Isopto Cetamide - Add your own review/rating Isopto Cetamide Prescribing Information (FDA) Bleph-10 Drops MedFacts Consumer Leaflet (Wolters Kluwer) Bleph-10 Prescribing Information (FDA) Compare Isopto Cetamide with other medications Conjunctivitis Trachoma Where can I get more information? Your pharmacist has additional information about sulfacetamide ophthalmic written for health professionals that you may read.

See also: Isopto Cetamide side effects (in more detail)


read more / Download


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