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Aphthous Stomatitis, Recurrent Medications


Drugs associated with Aphthous Stomatitis, Recurrent

The following drugs and medications are in some way related to, or used in the treatment of Aphthous Stomatitis, Recurrent. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Ala-Cort Ala-Scalp-Hp Anucort-Hc-Cream-Ointment-Suppository Anumed-Hc-Cream-Ointment-Suppository Aphthasol Aquanil-Hc Beta-Hc Caldecort Cetacort Cortaid Cortaid-Intensive-Therapy Cortaid-Maximum-Strength Cortaid-With-Aloe Cortalo-With-Aloe Corticaine Cortizone-For-Kids Cortizone-10-Cream Cortizone-10-Anal-Itch-Cream-Cream-Ointment-Suppository Cortizone-10-Intensive-Healing-Formula Cortizone-10-Plus Cortizone-5 Cotacort Dermarest-Dricort Dermarest-Eczema-Medicated Dermarest-Plus-Anti-Itch Dermtex-Hc Genasone-Aloe Gly-Cort Gynecort-Maximum-Strength Hemorrhoidal-Hc-Cream-Ointment-Suppository Hemril-30-Cream-Ointment-Suppository Hemril-Hc-Uniserts-Cream-Ointment-Suppository Hycort Hydrocortisone-1-In-Absorbase Hydrocortisone-With-Aloe-Cream Hytone-Cream Instacort-Gel Itch-X-Foam Lacticare-Hc Locoid-Cream Locoid-Lipocream Massengill-Medicated-Soft-Cloth Md-Hydrocortisone Neutrogena-T-Scalp Nucort-With-Aloe Nutracort-Lotion Nuzon Pandel Pediaderm-Hc-Lotion Procto-Kit-1-Cream-Ointment-Suppository Procto-Kit-2-5-Cream-Ointment-Suppository Procto-Pak-1-Cream-Ointment-Suppository Proctocare-Hc-Cream Proctocort-Cream-Ointment-Suppository Proctocream-Hc-Cream-Ointment-Suppository Proctosert-Hc-Cream-Ointment-Suppository Proctosol-Hc-Cream-Ointment-Suppository Proctozone-Hc-Cream-Ointment-Suppository Proctozone-H-Cream-Ointment-Suppository Recort-Plus Rectasol-Hc-Cream-Ointment-Suppository Rederm Sarnol-Hc Scalacort Scalpcort Scalpicin-Gel Texacort U-Cort Westcort-Cream
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Proctosol-HC cream, ointment, suppository


Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)
Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. 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.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

congestive heart failure;

a history of tuberculosis;

stomach ulcer or diverticulitis;

a colostomy or ileostomy;

fever or any type of infection;

kidney disease;

high blood pressure; or

myasthenia gravis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal 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 hydrocortisone 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 hydrocortisone rectal?

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.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them. 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.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

feeling short of breath, even with mild exertion;

swelling of your ankles or feet;

muscle weakness;

rapid weight gain, especially in your face and midsection;

severe rectal pain or burning;

bleeding from your rectum;

severe stomach pain;

sudden and severe headache or pain behind your eyes; or

seizure (convulsions).

Less serious side effects may include:

mild rectal pain or burning;

acne;

changes in your menstrual periods;

increased sweating; or

increased facial or body hair growth.

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 hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

There may be other drugs that can interact with hydrocortisone rectal. 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 Proctosol-HC resources Proctosol-HC Side Effects (in more detail) Proctosol-HC Use in Pregnancy & Breastfeeding Proctosol-HC Drug Interactions Proctosol-HC Support Group 2 Reviews for Proctosol-HC - Add your own review/rating Compare Proctosol-HC with other medications Anal Itching Aphthous Stomatitis, Recurrent Atopic Dermatitis Dermatitis Eczema Gingivitis Hemorrhoids Proctitis Pruritus Psoriasis Seborrheic Dermatitis Ulcerative Colitis, Active Where can I get more information? Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

See also: Proctosol-HC side effects (in more detail)


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Hydro 40 Foam


Pronunciation: ue-REE-a
Generic Name: Urea
Brand Name: Hydro 40 Foam
Hydro 40 Foam is used for:

Treating dry, rough, scaly skin caused by certain conditions (eg, dermatitis, psoriasis, eczema, cracked skin, calluses). It may also be used for certain other skin or nail conditions as determined by your doctor.

Hydro 40 Foam is a debriding agent. It works by helping the breakdown of dead skin, which helps to loosen and shed hard and scaly skin. It also softens and moisturizes the skin.

Do NOT use Hydro 40 Foam if: you are allergic to any ingredient in Hydro 40 Foam

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

Before using Hydro 40 Foam:

Some medical conditions may interact with Hydro 40 Foam. 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 the affected area is broken or severely irritated

Some MEDICINES MAY INTERACT with Hydro 40 Foam. Because little, if any, of Hydro 40 Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Hydro 40 Foam 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 Hydro 40 Foam:

Use Hydro 40 Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wash your hands immediately before and after using Hydro 40 Foam unless your hands are part of the treated area. Apply Hydro 40 Foam to the affected skin as directed by your doctor. Rub in gently until the medicine is completely absorbed. After you use Hydro 40 Foam, wipe any excess foam off of the container. If you miss a dose of Hydro 40 Foam and you are using it regularly, 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 Hydro 40 Foam.

Important safety information: Hydro 40 Foam is for external use only. Do not get it in your eyes, nose, mouth, or on your lips. If you get Hydro 40 Foam in your eyes, rinse them right away with cool water. Do not apply to broken or severely irritated skin. Do not use more than the recommended dose or use for longer than prescribed without checking with your doctor. Do not use Hydro 40 Foam for other skin conditions at a later time. PREGNANCY and BREAST-FEEDING: It is not known if Hydro 40 Foam can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydro 40 Foam while you are pregnant. It is not known if Hydro 40 Foam is found in breast milk. If you are or will be breast-feeding while you use Hydro 40 Foam, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Hydro 40 Foam:

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, temporary burning, itching, irritation, or stinging.

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); redness; severe or persistent burning or irritation.

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: Hydro 40 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.

Proper storage of Hydro 40 Foam:

Store Hydro 40 Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Avoid temperatures above 120 degrees F (49 degrees C). Do not freeze. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Hydro 40 Foam out of the reach of children and away from pets.

General information: If you have any questions about Hydro 40 Foam, please talk with your doctor, pharmacist, or other health care provider. Hydro 40 Foam 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 Hydro 40 Foam. 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 Hydro 40 resources Hydro 40 Side Effects (in more detail) Hydro 40 Use in Pregnancy & Breastfeeding Hydro 40 Support Group 0 Reviews for Hydro 40 - Add your own review/rating Compare Hydro 40 with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Kerafoam Foam


Pronunciation: ue-REE-a
Generic Name: Urea
Brand Name: Kerafoam
Kerafoam Foam is used for:

Treating dry, rough, scaly skin caused by certain conditions (eg, dermatitis, psoriasis, eczema, cracked skin, calluses). It may also be used for certain other skin or nail conditions as determined by your doctor.

Kerafoam Foam is a debriding agent. It works by helping the breakdown of dead skin, which helps to loosen and shed hard and scaly skin. It also softens and moisturizes the skin.

Do NOT use Kerafoam Foam if: you are allergic to any ingredient in Kerafoam Foam

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

Before using Kerafoam Foam:

Some medical conditions may interact with Kerafoam Foam. 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 the affected area is broken or severely irritated

Some MEDICINES MAY INTERACT with Kerafoam Foam. Because little, if any, of Kerafoam Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Kerafoam Foam 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 Kerafoam Foam:

Use Kerafoam Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wash your hands immediately before and after using Kerafoam Foam unless your hands are part of the treated area. Prime the container before the first use. To do this, point the container away from yourself and others. Hold it upright. Press down on the actuator for 3 to 5 seconds, or until foam begins to appear. Shake well before each use. To use Kerafoam Foam, hold the container upright. Apply Kerafoam Foam to the affected skin as directed by your doctor. Rub in gently until the medicine is completely absorbed. After you use Kerafoam Foam, wipe any excess foam off of the container. If you miss a dose of Kerafoam Foam and you are using it regularly, 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 Kerafoam Foam.

Important safety information: Kerafoam Foam is for external use only. Do not get it in your eyes, nose, mouth, or on your lips. If you get Kerafoam Foam in your eyes, rinse them right away with cool water. Do not apply to broken or severely irritated skin. Do not use more than the recommended dose or use for longer than prescribed without checking with your doctor. Do not use Kerafoam Foam for other skin conditions at a later time. PREGNANCY and BREAST-FEEDING: It is not known if Kerafoam Foam can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Kerafoam Foam while you are pregnant. It is not known if Kerafoam Foam is found in breast milk. If you are or will be breast-feeding while you use Kerafoam Foam, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Kerafoam Foam:

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, temporary burning, itching, irritation, or stinging.

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); redness; severe or persistent burning or irritation.

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: Kerafoam 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 ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Kerafoam Foam:

Store Kerafoam Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Avoid temperatures above 120 degrees F (49 degrees C). Do not freeze. Store upright away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Kerafoam Foam out of the reach of children and away from pets.

General information: If you have any questions about Kerafoam Foam, please talk with your doctor, pharmacist, or other health care provider. Kerafoam Foam 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 Kerafoam Foam. 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 Kerafoam resources Kerafoam Side Effects (in more detail) Kerafoam Use in Pregnancy & Breastfeeding Kerafoam Support Group 1 Review for Kerafoam - Add your own review/rating Compare Kerafoam with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Tersi Foam


Pronunciation: se-LEE-nee-um
Generic Name: Selenium
Brand Name: Tersi Foam
Tersi Foam is used for:

Treating scalp and skin conditions such as seborrhea or tinea versicolor (a fungal infection). It may also be used for other conditions as determined by your doctor.

Tersi Foam is a antiseborrheic and antifungal combination. It decreases skin cell growth associated with flaking and itching. It also kills sensitive fungi.

Do NOT use Tersi Foam if: you are allergic to any ingredient in Tersi Foam

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

Before using Tersi Foam:

Some medical conditions may interact with Tersi Foam. 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 broken, irritated, inflamed, or oozing skin at the application site

Some MEDICINES MAY INTERACT with Tersi Foam. Because little, if any, of Tersi Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Tersi Foam 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 Tersi Foam:

Use Tersi Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Remove jewelry before using Tersi Foam. Shake well before each use. Turn the container upside down to dispense medicine. Apply enough medicine to cover the affected area as directed by your doctor. Rub the medicine in until it is completely absorbed. Wash your hands immediately after using Tersi Foam. If you miss a dose of Tersi Foam, 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 Tersi Foam.

Important safety information: Tersi Foam is for external use only. Do not get Tersi Foam in your eyes, nose, mouth, or in the genital area. If you get it in any of these areas, rinse right away with cool water. If your symptoms do not get better or if they get worse, check with your doctor. Do not use more often or for longer than prescribed without checking with your doctor. If you use topical products too often, some conditions may become worse. Do not use Tersi Foam for another skin condition at a later time. Do not use Tersi Foam on broken, blistered, or inflamed skin. Tersi Foam may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Tersi Foam should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Tersi Foam while you are pregnant. It is not known if Tersi Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Tersi Foam, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Tersi Foam:

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:

Temporary mild stinging, burning, itching, or irritation 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); severe redness, stinging, burning, or irritation.

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: Tersi 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. Tersi Foam may be harmful if swallowed.

Proper storage of Tersi Foam:

Store Tersi Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Tersi Foam out of the reach of children and away from pets.

General information: If you have any questions about Tersi Foam, please talk with your doctor, pharmacist, or other health care provider. Tersi Foam 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 Tersi Foam. 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 Tersi resources Tersi Side Effects (in more detail) Tersi Use in Pregnancy & Breastfeeding Tersi Support Group 0 Reviews for Tersi - Add your own review/rating Tersi Foam Concise Consumer Information (Cerner Multum) Tersi Foam Topical Advanced Consumer (Micromedex) - Includes Dosage Information Tersi Foam Prescribing Information (FDA) Selsun Concise Consumer Information (Cerner Multum) Compare Tersi with other medications Seborrheic Dermatitis Tinea Versicolor
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U40 Foam


urea
Dosage Form: aerosol, foam
U40 Foam U40 Foam Description

U40 Foam is a keratolytic emollient in a water and lipid-based foam which is a gentle, but potent, tissue softener for skin and nails.
U40 Foam contains the active ingredient: Urea 40%. The inactive ingredients are: Carbomer, Colloidal Oatmeal, Dimethicone, Ethylparaben, Glycerine, Laureth 4, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylparaben, Propylene Glycol, Purified Water, Stearic Acid and Triethanolamine and in propellants Butane and Propane.
CHEMICAL STRUCTURE
Urea has the following chemical structure:

U40 Foam - Clinical Pharmacology

Urea, topically applied, dissolves the intercellular matrix of the skin which can result in enhanced shedding of scaly, dry skin which causes a softening of the hyperkeratotic areas of the skin. Applied to the nail plate topically, urea has a similar effect on the intercellular matrix of the nail plate.

PHARMACOKINETICS

The mechanism of action of topically applied urea is not yet known.

Indications and Usage for U40 Foam

For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is halted by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea, topically applied, is useful for the treatment of hyperkeratotic conditions such as dermatitis, xerosis, ichthyosis, psoriasis, eczema, keratosis, keratoderma and dry, rough skin, as well as corns and calluses. It is also useful in the treatment of damaged, ingrown and devitalized nails.

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings U40 Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips and all mucous membranes should be avoided. U40 Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.
Precautions U40 Foam should only be used as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. If redness or irritation occurs, discontinue use and consult with prescribing physician.
Pregnancy (Category C): Animal reproduction studies have not been performed with topically applied urea and it is not known whether U40 Foam can cause fetal harm when administered to pregnant women. U40 Foam should be used by pregnant women, only under a physician’s recommendation.
Nursing Mothers: It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering U40 Foam to nursing mothers.
KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN. Adverse Reactions Transient stinging, burning, itching or irritation is possible.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. U40 Foam Dosage and Administration Unless otherwise directed by a prescribing physician, U40 Foam should be applied to affected area twice a day. U40 Foam should be rubbed into the skin until it is completely absorbed.
How is U40 Foam Supplied

U40 Foam, NDC 49769-354-75, is supplied as (2) 2.63 oz (75 g), net wt. 5.26 oz (150 g), aerosolized canisters in a carton, NDC 49769-354-15.

U40 Foam is supplied in a 2.5 oz (70 g) aerosolized canister, NDC 49769-354-70.

Store at controlled room temperature 15?C - 25?C (59?F - 77?F).
Manufactured for
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Iss. 12/09
354-10

PACKAGING:

U40 Foam (75g) labeling:

U40 Foam (70g) labeling:


U40 
urea  aerosol, foam Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49769-354 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 400 mg  in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER 934   OATMEAL   DIMETHICONE   ETHYLPARABEN   GLYCERIN   LAURETH-4   METHYLPARABEN   PHENOXYETHANOL   POLYSORBATE 20   PROPYLPARABEN   PROPYLENE GLYCOL   WATER   STEARIC ACID   TROLAMINE   PROPANE   BUTANE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 49769-354-15 150 g In 1 CARTON None 2 49769-354-70 70 g In 1 CANISTER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/05/2010 06/30/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471) Revised: 03/2011Kylemore Pharmaceuticals, LLC More U40 Foam resources U40 Foam Side Effects (in more detail)U40 Foam Use in Pregnancy & Breastfeeding0 Reviews for U40 - Add your own review/rating Compare U40 Foam with other medications Dermatological DisordersDry SkinPityriasis rubra pilaris
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Uramaxin Foam


Pronunciation: ue-REE-a/a-MOE-nee-um LAK-tate
Generic Name: Urea in Ammonium Lactate
Brand Name: Examples include Ultralytic 2 and Uramaxin
Uramaxin Foam is used for:

Treating dry, rough, scaly skin caused by certain conditions (eg, dermatitis, psoriasis, eczema, cracked skin, calluses). It may also be used for certain other skin or nail conditions as determined by your doctor.

Uramaxin Foam is a keratolytic. It works by helping the breakdown of dead skin, which helps to loosen and shed hard and scaly skin. It also softens and moisturizes the skin.

Do NOT use Uramaxin Foam if: you are allergic to any ingredient in Uramaxin Foam

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

Before using Uramaxin Foam:

Some medical conditions may interact with Uramaxin Foam. 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 the affected area is broken or severely irritated

Some MEDICINES MAY INTERACT with Uramaxin Foam. Because little, if any, of Uramaxin Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Uramaxin Foam 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 Uramaxin Foam:

Use Uramaxin Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wash your hands immediately before and after using Uramaxin Foam unless your hands are part of the treated area. Prime the container before the first use. To do this, point the container away from yourself and others. Hold it upright. Press down on the actuator for 3 to 5 seconds, or until foam begins to appear. Shake well before each use. To use Uramaxin Foam, hold the container upright. Apply Uramaxin Foam to the affected skin as directed by your doctor. Rub in gently until the medicine is completely absorbed. After you use Uramaxin Foam, wipe any excess foam off of the container. If you miss a dose of Uramaxin Foam and you are using it regularly, 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 Uramaxin Foam.

Important safety information: Uramaxin Foam is for external use only. Do not get it in your eyes, nose, mouth, or on your lips. If you get Uramaxin Foam in your eyes, rinse them right away with cool water. Uramaxin Foam may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. If you use topical products too often, your condition may become worse. Do not apply to broken or severely irritated skin. Do not use more than the recommended dose or use for longer than prescribed without checking with your doctor. Do not use Uramaxin Foam for other skin conditions at a later time. Uramaxin Foam may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Uramaxin Foam. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Talk with your doctor before you use any other medicines or cleansers on your skin. PREGNANCY and BREAST-FEEDING: It is not known if Uramaxin Foam can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Uramaxin Foam while you are pregnant. It is not known if Uramaxin Foam is found in breast milk. If you are or will be breast-feeding while you use Uramaxin Foam, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Uramaxin Foam:

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, temporary burning, itching, irritation, or stinging at the application site.

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); redness; severe or persistent burning or irritation.

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, or emergency room immediately.

Proper storage of Uramaxin Foam:

Store Uramaxin Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Avoid temperatures above 120 degrees F (49 degrees C). Do not freeze. Store upright away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Uramaxin Foam out of the reach of children and away from pets.

General information: If you have any questions about Uramaxin Foam, please talk with your doctor, pharmacist, or other health care provider. Uramaxin Foam 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 Uramaxin Foam. 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 Uramaxin resources Uramaxin Use in Pregnancy & Breastfeeding Uramaxin Support Group 0 Reviews for Uramaxin - Add your own review/rating Compare Uramaxin with other medications Dermatitis Eczema Psoriasis
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Hydrating Foam


Pronunciation: Not applicable
Generic Name: Hydrating
Brand Name: Examples include Hylatopic and Neosalus
Hydrating Foam is used for:

Treating or preventing dry, itchy skin or minor skin irritations caused by various skin conditions, including atopic dermatitis and allergic contact dermatitis. Some brands of Hydrating Foam may also be used to treat radiation dermatitis.

Hydrating Foam is an emollient, protectant, and skin barrier combination. It works by moisturizing the skin and reducing skin irritation.

Do NOT use Hydrating Foam if: you are allergic to any ingredient in Hydrating Foam

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

Before using Hydrating Foam:

Some medical conditions may interact with Hydrating Foam. 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 the affected area has open sores or severe irritation

Some MEDICINES MAY INTERACT with Hydrating Foam. However, no specific interactions with Hydrating Foam are known at this time.

Ask your health care provider if Hydrating Foam 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 Hydrating Foam:

Use Hydrating Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

The container may need to be primed before the first use of Hydrating Foam. Check with your pharmacist to see if your container must be primed. If so, follow the instructions provided or ask your pharmacist how to prime the container. Wash your hands before and after using Hydrating Foam unless your hands are a part of the treated area. Shake well before each use. To dispense the foam from the container, follow the instructions provided with Hydrating Foam. If you are unsure how to dispense the foam, check with your pharmacist. Wash and completely dry the affected area with a mild or soapless cleanser. Apply enough of Hydrating Foam to completely cover the affected area and gently rub it in until it is evenly distributed and completely absorbed. Do not wrap or bandage the treated area unless directed to do so by your doctor. Wipe any excess foam off of the container after use. Additional skin moisturizers may be used if necessary. Contact your doctor if you have any questions. If you miss a dose of Hydrating Foam, 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.

Ask your health care provider any questions you may have about how to use Hydrating Foam.

Important safety information: Hydrating Foam is for external use only. Do not get Hydrating Foam in your eyes, nose, or mouth. If you get Hydrating Foam in any of these areas, rinse them right away with cool tap water. If you use topical products too often, your condition may become worse. Do not apply Hydrating Foam within 4 hours before a radiation session. Hydrating Foam may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Hydrating Foam. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Talk with your doctor before you use any other medicines or cleansers on your skin. If the symptoms do not improve, if they get worse, or if they clear up and then come back again, contact your doctor. Hydrating Foam may be flammable. Do not store near fire or an open flame. Avoid fire, open flame, or smoking during and immediately after use. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrating Foam while you are pregnant. It is not known if Hydrating Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Hydrating Foam, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Hydrating Foam:

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 burning, itching, dryness, redness, or scaling at the application site.

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); severe, persistent, or worsening itching, burning, redness, scaling, stinging, or irritation at the application site.

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, or emergency room immediately.

Proper storage of Hydrating Foam:

Store Hydrating Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat and direct sunlight. Do not freeze. Do not expose to heat or store at temperatures above 120 degrees F (49 degrees C). Do not puncture, break, or burn the canister, even if it appears to be empty. Keep Hydrating Foam out of the reach of children and away from pets.

General information: If you have any questions about Hydrating Foam, please talk with your doctor, pharmacist, or other health care provider. Hydrating Foam 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 Hydrating Foam. 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 Hydrating resources Hydrating Use in Pregnancy & BreastfeedingHydrating Support Group8 Reviews for Hydrating - Add your own review/rating Compare Hydrating with other medications Dry Skin
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Paptase Foam


Pronunciation: pa-PAY-in/ue-REE-a
Generic Name: Papain/Urea
Brand Name: Paptase
Paptase Foam is used for:

Removing dead tissue and thinning the pus in lesions such as ulcers, burns, wounds, and carbuncles.

Paptase Foam is a debriding agent. It works by helping the breakdown of dead skin and pus, which helps improve the recovery time of open wounds.

Do NOT use Paptase Foam if: you are allergic to any ingredient in Paptase Foam

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

Before using Paptase Foam:

Some medical conditions may interact with Paptase Foam. 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

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

Hydrogen peroxide or medicines containing silver, lead, or mercury because they may decrease Paptase Foam's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Paptase Foam 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 Paptase Foam:

Use Paptase Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Cleanse the affected area with saline or another mild wound cleansing solution each time the dressing is changed. Do not use hydrogen peroxide. Shake well before each use. You must prime the pump before you use it for the first time. Hold the can upright, pointed away from yourself and others. Push down the actuator until the foam begins to come out. The spray canister will work best if you hold it upright while you apply Paptase Foam; however, you may hold the canister at an angle if necessary. Apply Paptase Foam directly onto the wound or onto a secondary dressing as directed by your doctor. Apply Paptase Foam in a single layer as directed by your doctor. Completely cover the wound with medicine. Cover with appropriate dressing (eg, bandages) and secure into place. Wipe the nozzle with clean gauze after each use. Change wound dressings according to the schedule set by your doctor. If irritation occurs, talk with your doctor about changing the dressings more often. Protect the normal skin around the wound with a skin protectant as directed by your doctor. If you miss a dose of Paptase Foam, use it as soon as you remember. Continue to use it as directed by your doctor.

Ask your health care provider any questions you may have about how to use Paptase Foam.

Important safety information: Paptase Foam is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water. Do not puncture, break, or burn the canister, even if it appears to be empty. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Paptase Foam while you are pregnant. It is not known if Paptase Foam is found in breast milk. If you are or will be breast-feeding while you use Paptase Foam, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Paptase Foam:

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 skin irritation; temporary burning sensation.

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); severe or persistent skin irritation.

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: Paptase 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.

Proper storage of Paptase Foam:

Store Paptase Foam upright, in a cool place, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and direct sunlight. Avoid temperatures above 120 degrees F (49 degrees C). Do not puncture, break, or burn the canister even if it appears to be empty. Do not freeze. Keep Paptase Foam out of the reach of children and away from pets.

General information: If you have any questions about Paptase Foam, please talk with your doctor, pharmacist, or other health care provider. Paptase Foam 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 Paptase Foam. 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 Paptase resources Paptase Side Effects (in more detail) Paptase Use in Pregnancy & Breastfeeding Paptase Drug Interactions Paptase Support Group 0 Reviews for Paptase - Add your own review/rating Compare Paptase with other medications Burns, External Dermatologic Lesion Wound Cleansing
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Papain/Urea/Chlorophyllin Foam


Pronunciation: pa-PAY-in/ue-REE-a/KLOR-oh-FIL-in
Generic Name: Papain/Urea/Chlorophyllin
Brand Name: Papfyll
Papain/Urea/Chlorophyllin Foam is used for:

Removing dead tissue and thinning the pus in lesions such as ulcers, burns, wounds, and carbuncles.

Papain/Urea/Chlorophyllin Foam is a debriding agent. It works by helping the breakdown of dead skin and pus, which helps improve the recovery time of open wounds. It also helps to control wound inflammation and odor.

Do NOT use Papain/Urea/Chlorophyllin Foam if: you are allergic to any ingredient in Papain/Urea/Chlorophyllin Foam

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

Before using Papain/Urea/Chlorophyllin Foam:

Some medical conditions may interact with Papain/Urea/Chlorophyllin Foam. 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

Some MEDICINES MAY INTERACT with Papain/Urea/Chlorophyllin Foam. Tell your health care provider if you are taking any other medicines, especially any of the following:

Medicines containing silver, lead, or mercury because they may decrease Papain/Urea/Chlorophyllin Foam's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Papain/Urea/Chlorophyllin Foam 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 Papain/Urea/Chlorophyllin Foam:

Use Papain/Urea/Chlorophyllin Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Papain/Urea/Chlorophyllin Foam is for external use only. Before each use of Papain/Urea/Chlorophyllin Foam, clean the affected area with saline or another mild wound cleansing solution. Do not use hydrogen peroxide. Shake well before each use. The container must be primed before the first use. To prime, shake well. Point away from yourself and others and press down on the nozzle for 3 to 5 seconds or until foam appears. To use Papain/Urea/Chlorophyllin Foam, apply a single layer directly to the wound or to onto secondary dressing, as directed by your doctor. You may hold the container at an angle to spray the foam; however, it works best when held in an upright position. Completely cover the wound bed. Cover with appropriate dressing (eg, bandages), and secure into place. Wash the lesion each time the dressing is changed. Wipe any extra foam off of the nozzle with clean gauze after each use. Change wound dressings according to the schedule set by your doctor. If irritation occurs, talk with your doctor about changing the dressings more often. If you miss a dose of Papain/Urea/Chlorophyllin Foam, 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 Papain/Urea/Chlorophyllin Foam.

Important safety information: Papain/Urea/Chlorophyllin Foam is for external use only. Do not get it in the eyes, nose, or mouth. If you get it in any of these areas, rinse right away with a generous amount of cool water. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Papain/Urea/Chlorophyllin Foam while you are pregnant. It is not known if Papain/Urea/Chlorophyllin Foam is found in breast milk. If you are or will be breast-feeding while you use Papain/Urea/Chlorophyllin Foam, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Papain/Urea/Chlorophyllin Foam:

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 skin irritation; temporary burning sensation.

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).

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, or emergency room immediately.

Proper storage of Papain/Urea/Chlorophyllin Foam:

Store Papain/Urea/Chlorophyllin Foam upright at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Avoid temperatures above 120 degree F (49 degrees C). Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Papain/Urea/Chlorophyllin Foam out of the reach of children and away from pets.

General information: If you have any questions about Papain/Urea/Chlorophyllin Foam, please talk with your doctor, pharmacist, or other health care provider. Papain/Urea/Chlorophyllin Foam 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 Papain/Urea/Chlorophyllin Foam. 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 Papain/Urea/Chlorophyllin resources Papain/Urea/Chlorophyllin Use in Pregnancy & Breastfeeding Papain/Urea/Chlorophyllin Drug Interactions Papain/Urea/Chlorophyllin Support Group 2 Reviews for Papain/Urea/Chlorophyllin - Add your own review/rating Compare Papain/Urea/Chlorophyllin with other medications Burns, External Dermatologic Lesion Wound Cleansing
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Gelato Fluoride Foam


Generic Name: sodium fluoride
Dosage Form: aerosol, foam
This is a prescription fluoride treatment foam used to help prevent dental decay.

Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture on incinerate container. Do not spray toward open flame. For professional use only.

Distilled water, Polaxamer, Triethanolamine, Phosphoric Acid, Sodium Saccharine, Sodium Laureth Sulfate, Hydrofluoric Acid, Xylitol, Potassium Hydroxide, Propellant A31.

Store at controlled room temperature 59-86 F (15-30 C) Protect from freezing

GELATO FLUORIDE 
sodium fluoride  aerosol, foam Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68400-113 Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.5375 g  in 125 g Inactive Ingredients Ingredient Name Strength WATER   POLOXAMER 407   TROLAMINE   PHOSPHORIC ACID   SACCHARIN SODIUM   SODIUM BENZOATE   SODIUM LAURETH SULFATE   HYDROFLUORIC ACID   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68400-113-12 125 g In 1 BOTTLE, SPRAY None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/18/2012
Labeler - Deepak Products, inc. (124886743) Establishment Name Address ID/FEI Operations Deepak Products, inc. 124886743 manufacture Revised: 01/2012Deepak Products, inc.

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Hydro 35 Foam


urea in a water and lipid based foam containing lactic acid
Dosage Form: aerosol, foam
HYDRO 35™ Hydrating Topical Foam
(urea in a water and lipid based foam containing lactic acid, 35%)
Rx Only DESCRIPTION

HYDRO 35 is a keratolytic emollient in a water and lipid based foam containing lactic acid which is a gentle, but potent, tissue softener for skin and nails. Each gram of HYDRO 35 contains Urea 35% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, lactic acid, methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane.

CHEMICAL STRUCTURE

Urea has the following chemical structure:

CLINICAL PHARMACOLOGY

Topically applied urea dissolves the intercellular matrix of the skin which results in enhanced shedding of scaly, dry skin and thus a softening of the hyperkeratotic areas of the skin.

Urea topically applied to the nail plate has a similar effect on the intercellular matrix of the nail plate.

PHARMACOKINETICS

The mechanism of action of topically applied urea is not yet known.

INDICATIONS AND USAGE

For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris, or eschar. Topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, and dry, rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.

CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

WARNINGS

HYDRO 35 is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips and all mucous membranes should be avoided. HYDRO 35 should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.

PRECAUTIONS

HYDRO 35 should be used only as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. If redness or irritation occurs, discontinue use and consult with prescribing physician.

Pregnancy (Category B) - Animal reproduction studies have not been performed with topically applied urea and it is not known whether HYDRO 35 can cause fetal harm when administered to a pregnant woman. Nevertheless, HYDRO 35 should be used by a pregnant woman only if necessary.

Nursing Mothers - It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering HYDRO 35 to nursing mothers.

KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS

Transient stinging, burning, itching or irritation is possible.

DOSAGE AND ADMINISTRATION

Unless otherwise directed by a prescribing physician,

HYDRO 35 should be applied to affected area twice a day.

HYDRO 35 should be rubbed into the skin until it is completely absorbed.

HOW SUPPLIED

HYDRO 35 is supplied in a 150 gram or 5.3 ounce aerosolized canister bearing the NDC Number 23710-035-15 and a 22 gram or .79 ounce aerosolized canister bearing the NDC Number 23710-035-20. The 22g canister is a physician-dispensed sample product.

Store at controlled room temperature 15° - 25°C (59° - 77°F).

U.S. Patent Pending for HYDRO 35.

HYDRO 35 is manufactured for Quinnova Pharmaceuticals,

Inc., Newtown, PA 18940, (877) 660-6263,

www.QUINNOVA.com.

Prescribing Information as of May 2009.

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HYDRO 35 
urea in a water and lipid based foam containing lactic acid  aerosol, foam Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 23710-035 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 35 g  in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE   ETHYLPARABEN   GLYCERIN   LACTIC ACID   METHYLPARABEN   PHENOXYETHANOL   POLYSORBATE 20   POVIDONE   PROPYLENE GLYCOL   PROPYLPARABEN   WATER   STEARIC ACID   TROLAMINE   BUTANE   PROPANE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 23710-035-15 150 g In 1 CANISTER None 2 23710-035-20 22 g In 1 CANISTER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved other 06/20/2009
Labeler - Quinnova Pharmaceuticals, Inc. (607183766) Establishment Name Address ID/FEI Operations Bioglan Pharma AB Kosterogatan 426994992 manufacture Establishment Name Address ID/FEI Operations Aerosol Scandinavia 508349792 manufacture Establishment Name Address ID/FEI Operations Quinnova Pharmaceuticals, Inc. 607183766 import Revised: 08/2009Quinnova Pharmaceuticals, Inc. More Hydro 35 Foam resources Hydro 35 Foam Side Effects (in more detail) Hydro 35 Foam Use in Pregnancy & Breastfeeding Hydro 35 Foam Support Group 0 Reviews for Hydro 35 - Add your own review/rating Compare Hydro 35 Foam with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Kerafoam


urea
Dosage Form: aerosol, foam
Kerafoam
For softening, smoothing and removing rough scaling hyperkeratotic skin DESCRIPTION:

Kerafoam® Emollient Foam is a keratolytic emollient foam which is a tissue softener for skin and/or nails. Kerafoam Emollient Foam contains 30% urea USP in an aqueous based emollient foam vehicle. Each gram of Kerafoam Emollient Foam contains 30% urea USP, ammonium lactate, cetyl alcohol NF, emulsifying wax NF, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP, steareth-10. Also contains: Propellant HFA-134a (1,1,1,2-tetrafluoroethane).
Urea USP is a diamide of carbonic acid with the following chemical structure:

Kerafoam - Clinical Pharmacology

Urea gently lyses/dissolves the intercellular matrix of surface skin cells loosening and allowing a shedding of rough, thickened and scaly hyperkeratotic skin. Urea also moisturizes and softens skin.

INDICATIONS

For softening, smoothing and removing rough scaling hyperkeratotic skin in conditions such as xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

Contraindications

Known hypersensitivity to any of the listed ingredients. Discontinue use if hypersensitivity is observed.

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120?F (49?C).

Precautions Information for patients:

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Kerafoam Emollient Foam. It is not known whether Kerafoam Emollient Foam can cause fetal harm when administered to a  pregnant woman or can affect reproduction capacity. Kerafoam Emollient Foam should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Kerafoam Emollient Foam is administered to a nursing woman.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

Kerafoam Dosage and Administration

Shake Vigorously, Tap Bottom of Can, and Prime Before Initial Use. Shake Vigorously and Tap Before Each Use.
To Prime: After shaking, gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. Hold the can upright, direct away from the patient, and firmly depress the actuator for 1 to 3 seconds or until foam begins to dispense. (If foam does not dispense within 3 seconds: re-shake can, gently tap bottom of can onto a solid surface at least 3 times, and depress the actuator again until foam begins to dispense.)
Before Each Use: Shake vigorously and gently tap bottom of can onto palm of other hand or a solid surface at least 3 times.
During Use: Holding can upright, dispense Kerafoam into palm of hand and apply to affected area twice per day, or as directed by a physician. Rub in until completely absorbed. Wipe off any excess foam from actuator after use.

How is Kerafoam Supplied

Kerafoam Emollient Foam is supplied in a 60 g (NDC# 16781-157-60) aluminum can.

Store at room temperature: 59? - 77?F (15? - 25?C). Protect from freezing. Store upright.

Patent Pending

P/N 2604 Rev. 3

Manufactured For:

Onset Therapeutics
Cumberland, RI 02864

(888) 713-8154
www.onsettx.com

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Kerafoam Outer Carton - 5g

NDC 16781-157-06
Rx Only
Kerafoam®
Emollient Foam
Urea (30%)
For softening, smoothing, and removing rough scaling hyperkeratotic skin
See prescribing information enclosed

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Kerafoam Inner Label - 5g

NDC 16781-157-06
Rx Only
Professional Sample
Not for Sale
Net Weight 5g
Kerafoam®
Emollient Foam
Urea (30%)
Sample will not dispense entire contents.


Kerafoam 
urea  aerosol, foam Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16781-157 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 30 g  in 100 g Inactive Ingredients Ingredient Name Strength AMMONIUM LACTATE   PROPYLENE GLYCOL   CETYL ALCOHOL   PROPYLPARABEN   METHYLPARABEN   WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 16781-157-06 6 CAN In 1 BOX contains a CAN 1 5 g In 1 CAN This package is contained within the BOX (16781-157-06) 2 16781-157-11 6 CAN In 1 BOX contains a CAN 2 10 g In 1 CAN This package is contained within the BOX (16781-157-11) 3 16781-157-60 1 CAN In 1 BOX contains a CAN 3 60 g In 1 CAN This package is contained within the BOX (16781-157-60) 4 16781-157-96 1 CAN In 1 BOX contains a CAN 4 100 g In 1 CAN This package is contained within the BOX (16781-157-96)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/01/2006 12/31/2011
Labeler - Onset Dermatologics LLC (793223707) Registrant - Onset Dermatologics LLC (964275155) Establishment Name Address ID/FEI Operations Onset Dermatologics LLC 793223707 Manufacture Revised: 11/2011Onset Dermatologics LLC More Kerafoam resources Kerafoam Side Effects (in more detail) Kerafoam Use in Pregnancy & Breastfeeding Kerafoam Support Group 1 Review for Kerafoam - Add your own review/rating Kerafoam Foam MedFacts Consumer Leaflet (Wolters Kluwer) Aqua Care Cream MedFacts Consumer Leaflet (Wolters Kluwer) Hydro 35 Foam MedFacts Consumer Leaflet (Wolters Kluwer) Keralac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Keralac Nailstik Solution MedFacts Consumer Leaflet (Wolters Kluwer) Kerol MedFacts Consumer Leaflet (Wolters Kluwer) Ultra Mide Topical Advanced Consumer (Micromedex) - Includes Dosage Information Umecta Nail Film MedFacts Consumer Leaflet (Wolters Kluwer) Umecta PD Topical Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Uramaxin Foam MedFacts Consumer Leaflet (Wolters Kluwer) Compare Kerafoam with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Kerafoam 42


urea
Dosage Form: aerosol, foam
Kerafoam 42
For softening, smoothing and removing rough scaling hyperkeratotic skin DESCRIPTION:

KERAFOAM® 42 Emollient Foam is a keratolytic emollient foam which is a tissue softener for skin and/or nails. Each gram of Kerafoam 42 Emollient Foam contains 42% urea USP, ceteareth-10 phosphate, cetearyl alcohol NF, dicetyl phosphate, dl-alpha tocopheryl acetate USP, edetate disodium dihydrate USP, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP, sodium phosphate monobasic USP. Also contains: Propellant HFA-134a (1,1,1,2- tetrafluoroethane).
Urea USP is a diamide of carbonic acid with the following chemical structure:


Kerafoam 42 - Clinical Pharmacology

Urea gently lyses/dissolves the intercellular matrix of surface skin cells loosening and allowing a shedding of rough, thickened and scaly hyperkeratotic skin. Urea also moisturizes and softens skin.

INDICATIONS

For softening, smoothing and removing rough scaling hyperkeratotic skin in conditions such as xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

Contraindications

Known hypersensitivity to any of the listed ingredients. Discontinue use if hypersensitivity is observed.

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120?F (49?C).

Precautions Information for patients:

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Kerafoam 42 Emollient Foam. It is not known whether Kerafoam 42 Emollient Foam can cause fetal harm when administered to a  pregnant woman or can affect reproduction capacity. Kerafoam 42 Emollient Foam should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Kerafoam 42 Emollient Foam is administered to a nursing woman.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

Kerafoam 42 Dosage and Administration

Shake Vigorously, Tap Bottom of Can, and Prime Before Initial Use. Shake Vigorously and Tap Before Each Use.
To Prime: After shaking, gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. Hold the can upright, direct away from the patient, and firmly depress the actuator for 1 to 3 seconds or until foam begins to dispense. (If foam does not dispense within 3 seconds: re-shake can, gently tap bottom of can onto a solid surface at least 3 times, and depress the actuator again until foam begins to dispense.)
Before Each Use: Shake vigorously and gently tap bottom of can onto palm of other hand or a solid surface at least 3 times.
During Use: Holding can upright, dispense Kerafoam 42 into palm of hand and apply to affected area twice per day, or as directed by a physician. Rub in until completely absorbed. Wipe off any excess foam from actuator after use.

How is Kerafoam 42 Supplied

Kerafoam 42 Emollient Foam is supplied in a 60 g (NDC# 16781-181-60) and 100g (NDC# 16781-181-96) aluminum cans.

Store at room temperature: 59? - 77?F (15? - 25?C). Protect from freezing. Store upright.

Patent Pending

P/N 2614 Rev. 1

Manufactured For:

Onset Therapeutics
Cumberland, RI 02864

(888) 713-8154
www.onsettx.com

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Kerafoam42-Outer Box - 5g

NDC 16781-181-06
Rx Only
Kerafoam® 42
Emollient Foam Urea (42%)
For softening, smoothing, and removing rough scaling hyperkeratotic skin
See prescribing information enclosed
Professional Sample
Enclosed: Six 5g Samples
Available in 60g and 100g Cans


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Kerafoam42-Inner Label - 5g

NDC 16781-181-06
Rx Only
Professional Sample
Not for Sale
Net Weight 5g
Kerafoam® 42
Emollient Foam Urea (42%)
Sample will not dispense entire contents.


Kerafoam 42 
urea  aerosol, foam Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16781-181 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 42 g  in 100 g Inactive Ingredients Ingredient Name Strength WATER   PROPYLENE GLYCOL   SODIUM PHOSPHATE, MONOBASIC   CETOSTEARYL ALCOHOL   METHYLPARABEN   ALPHA-TOCOPHEROL ACETATE   EDETATE DISODIUM   PROPYLPARABEN   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 16781-181-06 1 CAN In 1 BOX contains a CAN 1 5 g In 1 CAN This package is contained within the BOX (16781-181-06) 2 16781-181-11 1 CAN In 1 BOX contains a CAN 2 10 g In 1 CAN This package is contained within the BOX (16781-181-11) 3 16781-181-60 1 CAN In 1 BOX contains a CAN 3 60 g In 1 CAN This package is contained within the BOX (16781-181-60) 4 16781-181-96 1 CAN In 1 BOX contains a CAN 4 100 g In 1 CAN This package is contained within the BOX (16781-181-96)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2009 12/31/2011
Labeler - Onset Dermatologics LLC (793223707) Registrant - Onset Dermatologics LLC (964275155) Establishment Name Address ID/FEI Operations Onset Dermatologics LLC 793223707 Manufacture Revised: 11/2011Onset Dermatologics LLC More Kerafoam 42 resources Kerafoam 42 Side Effects (in more detail) Kerafoam 42 Use in Pregnancy & Breastfeeding Kerafoam 42 Support Group 1 Review for Kerafoam 42 - Add your own review/rating Aqua Care Cream MedFacts Consumer Leaflet (Wolters Kluwer) Hydro 35 Foam MedFacts Consumer Leaflet (Wolters Kluwer) Kerafoam Foam MedFacts Consumer Leaflet (Wolters Kluwer) Keralac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Keralac Nailstik Solution MedFacts Consumer Leaflet (Wolters Kluwer) Kerol MedFacts Consumer Leaflet (Wolters Kluwer) Ultra Mide Topical Advanced Consumer (Micromedex) - Includes Dosage Information Umecta Nail Film MedFacts Consumer Leaflet (Wolters Kluwer) Umecta PD Topical Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Uramaxin Foam MedFacts Consumer Leaflet (Wolters Kluwer) Compare Kerafoam 42 with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Tersi Foam Topical


Generic Name: selenium sulfide (Topical route)

se-LEE-nee-um SUL-fide

Commonly used brand name(s)

In the U.S.

Dandrex Selenos Selseb Selsun Blue Medicated Treatment Tersi Foam

In Canada

Versel

Available Dosage Forms:

Lotion Cream Shampoo Foam Suspension

Therapeutic Class: Antiseborrheic

Uses For Tersi Foam

Selenium sulfide 1% and 2.5% strengths are used on the scalp to help control the symptoms of dandruff and seborrheic dermatitis.

Selenium sulfide 2.5% strength is used also on the body to treat tinea versicolor (a type of fungus infection of the skin).

In the United States, the 2.5% strength is available only with your doctor's prescription.

Before Using Tersi Foam

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of selenium sulfide in infants and children with use in other age groups; however, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of selenium sulfide in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Blistered, raw, or oozing areas on your scalp or body—Use of this medicine on these areas may increase the chance of absorption through the skin Proper Use of selenium sulfide

This section provides information on the proper use of a number of products that contain selenium sulfide. It may not be specific to Tersi Foam. Please read with care.

If you are using the 2.5% strength of selenium sulfide: Use this medicine only as directed. Do not use it more often than recommended on the label, unless otherwise directed by your doctor.

If you are using the 1% strength of selenium sulfide : For best results, use this medicine at least 2 times a week or as directed by your doctor.

To use selenium sulfide for dandruff or seborrheic dermatitis of the scalp:

Before using this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine (1 or 2 teaspoonfuls) to the scalp to work up a lather. Allow the lather to remain on the scalp for 2 to 3 minutes, then rinse. Apply the medicine again and rinse well. If this medicine is used on light or blond, gray, or chemically treated (bleached, tinted, permanent-waved) hair, rinse your hair well for at least 5 minutes after using the medicine to lessen the chance of hair discoloration. After treatment, wash your hands well.

To use selenium sulfide for tinea versicolor of the body:

Apply the medicine to the affected areas of your body, except for your face and genitals (sex organs). Work up a lather using a small amount of water. Allow the medicine to remain on your skin for 10 minutes. Rinse your body well to remove all the medicine.

Do not use this medicine if blistered, raw, or oozing areas are present on your scalp or the area of your body that is to be treated , unless otherwise directed by your doctor.

Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For lotion dosage form: For dandruff or seborrheic dermatitis: Adults and children—If you are using the 1% lotion, use on the scalp two times a week. If you are using the 2.5% lotion, use on the scalp two times a week for two weeks, then use one time a week or less often. Infants—Use and dose must be determined by your doctor. For tinea versicolor: Adults and children—Use the 2.5% lotion on the body one time a day for seven days. Infants—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tersi Foam

If your condition does not get better after regular use of this medicine, or if it gets worse, check with your doctor.

Tersi Foam Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare Skin irritation

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Unusual dryness or oiliness of hair or scalp Less common Increase in normal hair loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Tersi Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tersi Foam Topical resources Tersi Foam Topical Side Effects (in more detail)Tersi Foam Topical Use in Pregnancy & BreastfeedingTersi Foam Topical Support Group0 Reviews for Tersi Topical - Add your own review/rating Compare Tersi Foam Topical with other medications Seborrheic DermatitisTinea Versicolor
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Selsun Blue 2 in 1


Generic Name: selenium sulfide topical (se LEE nee um SUL fide TOP ik al)
Brand Names: Dandrex, Head & Shoulders Intensive Treatment, Selenos, Selseb, Selsun Blue, Selsun Blue 2 in 1, Selsun Blue Balanced Treatment, Selsun Blue Moisturizing Treatment, Tersi Foam

What is Selsun Blue 2 in 1 (selenium sulfide topical)?

Selenium sulfide is an antifungal medication. It prevents fungus from growing on your skin.

Selenium sulfide topical (for the skin) is used to treat dandruff, seborrhea, and tinea versicolor (a fungus that discolors the skin).

Selenium sulfide topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Selsun Blue 2 in 1 (selenium sulfide topical)? Avoid getting this medication in your eyes, nose, or mouth. If it does get into any of these areas, rinse with water. Do not use selenium sulfide topical on sunburned, windburned, dry, chapped, or broken skin.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not cover treated skin with a bandage or other dressing unless your doctor has told you to. A light cotton-gauze bandage may be used to protect clothing. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Stop using selenium sulfide and call your doctor if you have unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin. What should I discuss with my healthcare provider before using Selsun Blue 2 in 1 (selenium sulfide topical)? You should not use this medication if you are allergic to selenium sulfide. FDA pregnancy category C. It is not known whether selenium sulfide is harmful to an unborn baby. Before using selenium sulfide topical, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether selenium sulfide 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 Selsun Blue 2 in 1 (selenium sulfide topical)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Shake the selenium sulfide foam well just before each use. Wash your hands after applying this medication.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not cover treated skin with a bandage or other dressing unless your doctor has told you to. A light cotton-gauze bandage may be used to protect clothing.

Store this medication at room temperature away from moisture and heat. Keep the medicine canister away from open flame, and do not puncture the can. What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of selenium sulfide topical is not likely to produce life-threatening side effects.

What should I avoid while using Selsun Blue 2 in 1 (selenium sulfide topical)? Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If it does get into any of these areas, rinse with water. Do not use selenium sulfide topical on sunburned, windburned, dry, chapped, or broken skin.

Avoid covering treated skin areas with tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Selsun Blue 2 in 1 (selenium sulfide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using selenium sulfide and call your doctor if you have unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the 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 Selsun Blue 2 in 1 (selenium sulfide topical)?

Avoid using other topical medications at the same time you apply selenium sulfide topical, unless your doctor approves. Other skin medications may affect the absorption or effectiveness of selenium sulfide topical.

More Selsun Blue 2 in 1 resources Selsun Blue 2 in 1 Side Effects (in more detail) Selsun Blue 2 in 1 Use in Pregnancy & Breastfeeding Selsun Blue 2 in 1 Support Group 0 Reviews for Selsun Blue 2 in - Add your own review/rating Dandrex Topical Advanced Consumer (Micromedex) - Includes Dosage Information Dandrex Lotion MedFacts Consumer Leaflet (Wolters Kluwer) Selseb MedFacts Consumer Leaflet (Wolters Kluwer) Tersi Foam Prescribing Information (FDA) Tersi Foam MedFacts Consumer Leaflet (Wolters Kluwer) Compare Selsun Blue 2 in 1 with other medications Seborrheic Dermatitis Tinea Versicolor Where can I get more information? Your pharmacist can provide more information about selenium sulfide topical.

See also: Selsun Blue 2 in side effects (in more detail)


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Ulcerative Colitis Medications


Definition of Ulcerative Colitis: Ulcerative colitis is a chronic, episodic, inflammatory disease of the large intestine and rectum characterized by bloody diarrhea.

Drugs associated with Ulcerative Colitis

The following drugs and medications are in some way related to, or used in the treatment of Ulcerative Colitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Ulcerative Colitis Ulcerative Colitis, Active (55 drugs) Ulcerative Colitis, Maintenance (12 drugs) Learn more about Ulcerative Colitis

Micromedex Care Notes:

Ulcerative Colitis

Medical Encyclopedia:

Ulcerative colitis

Harvard Health Guide:

Symptoms and treatment for Ulcerative Colitis
Drug List: A-Hydrocort Acthar Apriso Asacol Asacol-Hd-Delayed-Release-Tablets Azasan Azulfidine Azulfidine-En-Tabs-Delayed-Release-Tablets Baycadron Canasa-Suppositories Canasa-Pac-Rectal Catapres Colazal Colocort-Enema Cortenema-Enema Cortifoam-Foam-Enema De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Dipentum Gengraf Hp-Acthar-Gel Imuran Lialda Mesasal-Rectal Meticorten Neoral Pentasa Remicade Rowasa-Enema Salofalk-Rectal Sandimmune Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Sulfazine Zema-Pak-10-Day
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Selsun Blue Moisturizing Treatment


Generic Name: selenium sulfide topical (se LEE nee um SUL fide TOP ik al)
Brand Names: Dandrex, Head & Shoulders Intensive Treatment, Selenos, Selseb, Selsun Blue, Selsun Blue 2 in 1, Selsun Blue Balanced Treatment, Selsun Blue Moisturizing Treatment, Tersi Foam

What is Selsun Blue Moisturizing Treatment (selenium sulfide topical)?

Selenium sulfide is an antifungal medication. It prevents fungus from growing on your skin.

Selenium sulfide topical (for the skin) is used to treat dandruff, seborrhea, and tinea versicolor (a fungus that discolors the skin).

Selenium sulfide topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Selsun Blue Moisturizing Treatment (selenium sulfide topical)? Avoid getting this medication in your eyes, nose, or mouth. If it does get into any of these areas, rinse with water. Do not use selenium sulfide topical on sunburned, windburned, dry, chapped, or broken skin.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not cover treated skin with a bandage or other dressing unless your doctor has told you to. A light cotton-gauze bandage may be used to protect clothing. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Stop using selenium sulfide and call your doctor if you have unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin. What should I discuss with my healthcare provider before using Selsun Blue Moisturizing Treatment (selenium sulfide topical)? You should not use this medication if you are allergic to selenium sulfide. FDA pregnancy category C. It is not known whether selenium sulfide is harmful to an unborn baby. Before using selenium sulfide topical, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether selenium sulfide 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 Selsun Blue Moisturizing Treatment (selenium sulfide topical)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Shake the selenium sulfide foam well just before each use. Wash your hands after applying this medication.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not cover treated skin with a bandage or other dressing unless your doctor has told you to. A light cotton-gauze bandage may be used to protect clothing.

Store this medication at room temperature away from moisture and heat. Keep the medicine canister away from open flame, and do not puncture the can. What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of selenium sulfide topical is not likely to produce life-threatening side effects.

What should I avoid while using Selsun Blue Moisturizing Treatment (selenium sulfide topical)? Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If it does get into any of these areas, rinse with water. Do not use selenium sulfide topical on sunburned, windburned, dry, chapped, or broken skin.

Avoid covering treated skin areas with tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Selsun Blue Moisturizing Treatment (selenium sulfide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using selenium sulfide and call your doctor if you have unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the 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 Selsun Blue Moisturizing Treatment (selenium sulfide topical)?

Avoid using other topical medications at the same time you apply selenium sulfide topical, unless your doctor approves. Other skin medications may affect the absorption or effectiveness of selenium sulfide topical.

More Selsun Blue Moisturizing Treatment resources Selsun Blue Moisturizing Treatment Side Effects (in more detail) Selsun Blue Moisturizing Treatment Use in Pregnancy & Breastfeeding Selsun Blue Moisturizing Treatment Support Group 0 Reviews for Selsun Blue Moisturizing Treatment - Add your own review/rating Dandrex Topical Advanced Consumer (Micromedex) - Includes Dosage Information Dandrex Lotion MedFacts Consumer Leaflet (Wolters Kluwer) Selseb MedFacts Consumer Leaflet (Wolters Kluwer) Tersi Foam Prescribing Information (FDA) Tersi Foam MedFacts Consumer Leaflet (Wolters Kluwer) Compare Selsun Blue Moisturizing Treatment with other medications Seborrheic Dermatitis Tinea Versicolor Where can I get more information? Your pharmacist can provide more information about selenium sulfide topical.

See also: Selsun Blue Moisturizing Treatment side effects (in more detail)


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Proctofoam HC


Proctofoam HC 1% w/w & 1% w/w Rectal Foam

(Hydrocortisone acetate & pramocaine hydrochloride)

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours Throughout this leaflet Proctofoam HC 1 % w/w & 1 % w/w Rectal Foam is called Proctofoam. Important: Proctofoam is a steroid medicine, prescribed for many different conditions, including serious illnesses You need to use it regularly to get the maximum benefit Don't stop using this medicine without talking to your doctor - you may need to reduce the dose gradually Proctofoam can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed, or 'high'), or stomach problems can happen straight away. If you feel unwell in any way, keep using your medicine, but see your doctor straight away Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information) Keep away from people who have chicken-pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away. Now read the rest of this leaflet.

It includes other important information on the safe and effective use of this medicine that might be especially important for you.

In this leaflet: 1. What Proctofoam is for 2. Before you use Proctofoam 3. How to use Proctofoam 4. Possible side effects 5. How to store Proctofoam 6. Further information What Proctofoam is for Proctofoam - benefit information

Proctofoam belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Proctofoam) is an effective way to treat various illnesses involving inflammation in the body.

Proctofoam reduces this inflammation, which could otherwise go on making your condition worse You must use this medicine regularly to get maximum benefit from it. Proctofoam is used for the relief of inflammation, itching, pain, swelling and irritation associated with haemorrhoids (piles) and certain other conditions of the anus (bottom) and anal region.

Before you use Proctofoam Do not use Proctofoam: If you are allergic to pramocaine hydrochloride or to any other ingredient in Proctofoam (see section 6) If you are suffering from a bacterial infection, viral infection or fungal infection

Proctofoam is not for use in children

If any of the above applies to you talk to your doctor or pharmacist.

Check with your doctor first: If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while using steroid medicines like Proctofoam. If any of your close family has had these illnesses If you have diseases of the bowel (rectum).

If any of these applies to you, talk to your doctor before using Proctofoam.

Taking other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Proctofoam.

How to use Proctofoam

Always use Proctofoam exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it is not, or you are not sure, ask your doctor or pharmacist.

Remember: Do not use Proctofoam for more than 7 days Talk to your doctor if symptoms worsen, or do not improve within 7 days or if bleeding occurs You need to use your medicine regularly to get the maximum benefit. Adult dose

Proctofoam can be applied in the rectum (internal use) or to the skin around the anus (external use).

The usual dose into the rectum is one applicator of foam two or three times per day and after each bowel evacuation up to a maximum of 4 times daily For the anal area expel a small amount of foam onto two fingers and apply to the affected area. For internal use 1. Shake the canister vigorously for 30 seconds before each use. 2. Withdraw the plunger until it stops at the catch line. 3. Hold the applicator upright and insert the canister top into the applicator tip. Make sure you hold the plunger and applicator body FIRMLY with your fingers. 4. Press down gently on the canister top with your fingers, so that the foam fills about ? of the applicator body. Only a short press is needed to do this. 5. Wait for a few seconds until the foam stops expanding.
DO NOT fill the applicator in one go. Always release the canister top after a short press. 6. Repeat steps 4 & 5 above until the foam expands to just reach the 'Fill' line. This normally takes 2 to 4 short press/wait. 7. Stand with one leg raised on a chair, or lie down on your side. Hold the applicator as shown. Insert gently into the back passage and push the plunger fully into the applicator. For topical use

Shake the canister vigorously for 30 seconds before each use. Expel a small quantity of foam onto a tissue, pad or two fingers and apply the foam to the affected area.

After using the applicator Always take the applicator apart and wash it thoroughly after use The canister top should also be removed and washed Replace the canister top with care. Make sure it is placed vertically on top of the canister, and not at an angle. If you use more Proctofoam than you should

If you use too much go to your doctor as soon as possible.

If you repeatedly use too much Proctofoam you may experience fattening of the face, neck and body, hair growing on your body (women), a dusky complexion with purple patches and skin thinning.

If you forget to use Proctofoam

Do not use double the dose to make up for a missed dose. Simply take your next dose as planned.

If you stop using Proctofoam

Do not stop using Proctofoam without talking to your doctor. Your doctor may reduce your dose gradually.

Mental problems while using Proctofoam

Mental health problems can happen while using steroids like Proctofoam (see also section 4 Possible Side Effects).

These illnesses can be serious Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone using this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Proctofoam HC Side Effects

Like all medicines, Proctofoam can cause side effects, although not everybody gets them.

Serious effects: tell your doctor straight away

Steroids can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines that contain steroids.

Feeling depressed, including thinking about suicide Feeling high (mania) or moods that go up and down Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Other side effects

If you get any of the following, keep using the medicine but tell your doctor:

Unexpected fattening of the face, neck and body Irregular periods Hair starts to grow on your body (women) Dusky complexion with purple patches Skin thinning Allergic skin reaction Infection Burning sensation Itching.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Proctofoam

Keep out of the reach and sight of children.

Do not use Proctofoam after the expiry date which is stated on the canister and carton. The expiry date refers to the last day of that month.

Do not expose to temperatures above 50°C. Keep in the original packaging to protect from sunlight Do not refrigerate Keep away from sources of ignition Do not spray on a naked flame or anything hot Do not pierce or burn the container even after use.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Further information What Proctofoam contains:

The active substances in Proctofoam are hydrocortisone acetate (1 % w/w) and pramocaine hydrochloride (1% w/w).

The other ingredients are cetyl alcohol, emulsifying wax (cetyl alcohol, sorbitan solution), methyl parahydroxybenzoate (E218), polyoxyethylene (10); stearyl ether, propylene glycol, propyl parahydroxybenzoate (E216), trolamine, purified water and propellant HP-70 consisting of isobutane and propane.

What Proctofoam looks like

Proctofoam is a white rectal foam contained in a pressurised canister.

Contents of the pack

Each pack contains canister and a plastic applicator.

Each canister contains approximately 40 doses.

Marketing Authorisation Holder in the UK: Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK Manufacturer Pharmasol Limited North Way Walworth Industrial Estate Andover SP10 5AZ UK

This leaflet was last approved in January 2010.

If this leaflet is difficult to see or read or you would like it in a different format, please contact:

In the UK -

Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
UK

Proctofoam is a registered trademark of Meda AB.

MP00697


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CLARELUX cutaneous foam


CLARELUX 500 microgram/g cutaneous foam in pressurised container

(Clobetasol propionate)

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What CLARELUX is and what it is used for
2. Before you use CLARELUX
3. How to use CLARELUX
4. Possible side effects
5. How to store CLARELUX
6. Further Information

What Clarelux Is And What It Is Used For

CLARELUX is a foam to be applied to the skin, containing 500 microgram/g clobetasol propionate as the active ingredient. Clobetasol propionate belongs to a group of medicines known as topical corticosteroids.

CLARELUX is one of the stronger corticosteroids and is used as a short-term treatment for scalp conditions, e.g. psoriasis of the scalp, which do not respond satisfactorily to weaker corticosteroids.

Before You Use Clarelux Do not use CLARELUX: If you are allergic to clobetasol propionate, to other corticosteroids or any of the other ingredients of CLARELUX If you suffer from burns and other skin condition such as rosacea, acne, skin inflammation around the mouth, itching (pruritus) around the anus or genitals, or have a skin infection On any area of your body or face, apart from your scalp. Take special care with CLARELUX

As with all topical corticosteroids, CLARELUX can be absorbed through the skin and can cause side effects- see Section 4 for all possible side effects. Due to this:

Long-term treatment with CLARELUX should be avoided. CLARELUX should not be applied to a large surface area. The treated areas should not be bandaged or covered unless directed by your doctor

When your skin condition is better or after a maximum duration treatment of two weeks, your doctor should modify or change your treatment.

Inform your doctor:

If your condition does not improve after 2 weeks of treatment. If an infection occurs, as this may require discontinuation of treatment with CLARELUX. If you have a problem with your liver. If you start to experience problems with your vision, as this type of medicine may increase the development of cataracts.

Children and adolescents: Treatment is not recommended in children and adolescents.

Driving and using machines: CLARELUX should not affect your ability to drive or operate machines.

Using other Medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breast-feeding

Please inform your doctor if you are pregnant, planning to become pregnant, breast-feeding or planning to breast-feed. CLARELUX should not be used during pregnancy or breast-feeding unless advised by your doctor.

Important information about some of the ingredients in CLARELUX

CLARELUX contains propylene glycol, which may cause skin irritation. It also contains cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

How To Use Clarelux

WARNINGS:

The canister contains a pressurised, flammable liquid.

Do not use or store near a naked flame, source of ignition, any heat generating material or electrical device in use.

Do not smoke whilst using or holding this can.

Always use CLARELUX exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Use this medication only for the condition for which it was prescribed. CLARELUX must only be applied to the scalp and should not be swallowed.

Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin.

Apply CLARELUX to the affected area of the scalp twice a day, once in the morning and once at night, as follows:

1. Shake the can well.

2. Turn the can upside down and squirt a small amount (the size of a walnut) either directly onto the scalp, or into the cap of the can, onto a saucer or other cool surface and then onto the scalp.
Clarelux should always be applied thinly, so use as little as possible when covering the affected areas. The exact amount you need depends on the size of the affected area.
Do not apply to the eyelids and take care to avoid contact with eyes, nose, and mouth.
Do not squirt CLARELUX onto your hands, as the foam will begin to melt immediately upon contact with warm skin.

3. Move the hair away from the foam and gently massage into the scalp, until it disappears and is absorbed. Repeat if necessary, to treat the entire affected area.

Wash your hands after applying CLARELUX and discard any unused foam.

Do not use CLARELUX on your face. If some foam accidentally gets into your eyes, nose or mouth, rinse immediately with cold water. You may feel a stinging sensation. Contact your doctor, if the pain continues.

The treated areas should not be bandaged or covered unless directed by your doctor.

Do not wash or rinse the treated scalp areas immediately after applying CLARELUX.

Do not use more than 50g of CLARELUX foam per week.

Treatment should not be given for more than 2 weeks. After this period CLARELUX may be used occasionally if needed. Alternatively your doctor may prescribe a weaker steroid to control your condition.

If you use more CLARELUX than you should

If you use CLARELUX Foam in a larger quantity or for a long period of time without your doctor’s knowledge you should tell your doctor immediately.

If you forget to use CLARELUX, use it as soon as you remember, then continue as before. If you only remember at the time of your next dose, use a single dose and continue as before (do not apply a double dose to make up for the forgotten dose). If you miss several doses, tell your doctor.

If you stop using CLARELUX

Do not stop using CLARELUX suddenly as this may harm you. Your doctor may need to discontinue the treatment gradually and you may need regular check-ups.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, CLARELUX can cause side effects, although not everybody gets them.

Stop using CLARELUX and contact your doctor immediately if hypersensitivity reactions occur, such as local irritation.

The side effects may include:

Common side effects (occurring in less than 1 in 10 people but more than 1 in 100):

Burning sensation Other skin reaction when applied to the skin

Very rare effects (occurring in less than 1 in 10,000 people):

Sensation of tingling or pricking Eye irritation Swollen veins Skin irritation and tenderness Skin tightness Itchy skin rash (contact dermatitis) Aggravated scaly skin rash (psoriasis aggravated) Redness at the application site Itching and sometimes with pain at the application site Presence of blood, protein and nitrogen in your urine may be detected by a doctor

Additional side effects may include:

Changes in hair growth (abnormal hair growth away from the application site and on unusual parts of the body ) Changes in skin colour Irritation of the hair follicules e.g. pain, heat and redness Mouth rashes Redness and eruptions on the face Delay in wound healing Effects on the eyes

Side effects caused by pronged use include:

White markings on skin (striae) and dilatation of the blood vessels of the skin As with other topical corticosteroids, when CLARELUX is used in large amounts and for a long period of time, this can lead to a disorder called Cushing’s syndrome which symptoms include a red, puffy and rounded face (called a moon face), high blood pressure, weight gain and changes in sugar levels in the blood and urine. Prolonged treatment with steroids may cause thinning of the skin.

In rare instances, treatment of psoriasis with corticosteroids (or on stopping treatment) may make the condition worse and a pustular form of the disease may occur. On stopping treatment with corticosteroids, sometimes, the scalp condition may return. Also pre-existing infections may worsen if CLARELUX is not used according to the instructions. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Clarelux The canister contains a pressurised, flammable liquid. Do not store near a naked flame, source of ignition, any heat generating material or electrical device in use. Do not expose to temperatures higher than 50?C or to direct sunlight. Do not pierce or burn the can even when empty. When you have finished your treatment, dispose of the can safely.

Keep out of the reach and sight of children.

Do not use CLARELUX after the expiry date which is stated on the can and the outer carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not refrigerate. Store upright.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Clarelux Contains

1 g of CLARELUX contains 500 microgram of clobetasol propionate as active substance.

The other ingredients are: ethanol anhydrous, purified water, propylene glycol, cetyl alcohol, stearyl alcohol, polysorbate 60, citric acid anhydrous, potassium citrate and a propane/n-butane/isobutane propellant mixture.

What Clarelux Looks Like And Contents Of The Pack

CLARELUX is a cutaneous white foam. Each can of CLARELUX contains 50 or 100 grams.

Marketing Authorisation Holder : Pierre Fabre Dermatologie 45 place Abel Gance 92100 Boulogne France Manufacturer : Aerosol Service Italiana S.R.L. (ASI) Via del Maglio,6 23868 Valmadrera (LC) Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

CLARELUX 500 microgram/g cutaneous foam in Austria, Belgium, Finland, Germany, Greece, Iceland, Ireland, Luxemburg, The Netherlands, Norway, Portugal, United-Kingdom and Spain.

OLUX 500 microgram/g cutaneous foam in Italy.

For any information on this product please contact:

Pierre Fabre Ltd Phone: + 44 (0)1962 874400

Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information:

United Kingdom: Clarelux PL20693/0004

Ireland: Clarelux PA1230/1/1

This is a service provided by the Royal National institute of the blind.

Clarelux is a trademark of Pierre Fabre Dermatologie.

Sold under Stiefel License - Patent n° GB 9504265

This leaflet was last approved in June 2008.


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