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Aquadrate 10% w / w Cream


Aquadrate 10% w/w Cream

(Urea)

What is this leaflet about?

This leaflet is a summary of information about Aquadrate Cream. Read it carefully and keep it in case you need to refer to it again. If you have any questions about the cream, or your illness, ask your pharmacist (chemist) or doctor.

What is in Aquadrate Cream?

Aquadrate Cream contains the active ingredient Urea (10% w/w) and comes in tubes of 30g and 100g. Each 30g/100g tube contains 3g/10g of urea.

The cream also contains white soft paraffin, maize starch, isopropyl myristate, glyceryl tribehenate, palmitic acid, sorbitan laurate and polyoxyethylene fatty glyceride.

Who makes Aquadrate Cream?

The Marketing Authorisation holder is

Alliance Pharmaceuticals Ltd Avonbridge House Chippenham Wiltshire SN15 2BB England

and is licensed to sell Aquadrate Cream in the UK and Eire. It is made by

Laboratoires Chemineau Vouvray France What is Aquadrate Cream used for?

It is used to treat dry, scaly skin conditions. The urea in the cream helps to soften and moisturise your skin.

Is Aquadrate Cream right for you?

Tell your doctor if :

you are using any other medicines that are applied to the skin, as Aquadrate might affect the action of the other medicine. you have ever had a reaction to this cream or to any of its ingredients (these are listed above). you are pregnant or breastfeeding. the cream irritates your skin or there is no improvement in your condition. How to use Aquadrate Cream

The cream is for external use only and should only be applied to the skin. It should not be used on moist or broken skin. Application of Aquadrate Cream may cause skin irritation (redness, burning or itching). If you forget to use the cream on any occasion, do not worry, just continue as normal.

Adults, Children and the Elderly:-

Wash affected areas well, rinse off all traces of soap, dry and apply a small amount of the cream twice daily. Your doctor may tell you to cover this with a special "occlusive" dressing, but this is not usually necessary.

Does Aquadrate Cream have side effects?

If used correctly, as directed by your doctor, the cream is unlikely to cause side effects.

Some people experience irritation when they apply the cream. If you notice this or any other unusual effect, tell your doctor.

Storing Aquadrate Cream

Keep all medicines out of the reach and sight of children and do not store above 30°C.

Do not use after the expiry date shown on the base of the tube.

PL Number 16853/0061

PA Number: 943/5/1

Legal category: P

This leaflet was last revised in May 2006

Aquadrate is a registered Trade mark

©Alliance Pharmaceuticals, Limited

AN 0729 004


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Amino-Cerv Cream


Pronunciation: uh-MEE-no AS-ids/SO-dee-uhm PRO-pee-oh-nate/you-REE-ah
Generic Name: Amino Acids/Sodium Propionate/Urea Cervical
Brand Name: Amino-Cerv
Amino-Cerv Cream is used for:

Treating inflammation or injury of the cervix. It is usually used after childbirth or certain medical procedures. It may also be used to treat other conditions as determined by your doctor.

Amino-Cerv Cream is an amino acid, antifungal, and urea combination. The amino acids help wounds to heal. They also help to increase cell growth. Sodium propionate kills sensitive fungi. Urea helps to break down dead tissue. It also increases new tissue growth.

Do NOT use Amino-Cerv Cream if: you are allergic to any ingredient in Amino-Cerv Cream

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

Before using Amino-Cerv Cream:

Some medical conditions may interact with Amino-Cerv Cream. 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 preparations, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Amino-Cerv Cream. Because little, if any, of Amino-Cerv Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amino-Cerv Cream 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 Amino-Cerv Cream:

Use Amino-Cerv Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Amino-Cerv Cream. Talk to your pharmacist if you have questions about this information. Use Amino-Cerv Cream before going to bed unless directed otherwise by your doctor. If you are wearing a pessary, remove it before you use Amino-Cerv Cream. Do not tape over the pinhole on the top of the bulb on the applicator. To use Amino-Cerv Cream, attach the applicator to the tube. Squeeze the tube from the bottom until the medicine reaches the correct dose mark on the applicator. Detach the applicator from the tube. Insert it 3 4 inch into the vagina. Do NOT insert it all the way into the vagina. Squeeze the bulb firmly once. This will deposit the cream into the vagina. Do not release the bulb until you have removed the applicator from the vagina. Clean the applicator right away. Hold it under water and flush it (squeeze the bulb) several times. Wipe the threads of the tube and the inside of the cap. Recap the tube tightly. Do not use other feminine sprays or vaginal or cervical medicines. They may interact with Amino-Cerv Cream. If you miss a dose of Amino-Cerv Cream, use it as soon as possible. If you do not remember until the next day, skip the missed dose. 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 Amino-Cerv Cream.

Important safety information: Amino-Cerv Cream is for vaginal use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool water. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amino-Cerv Cream while you are pregnant. It is unknown if Amino-Cerv Cream is found in breast milk. If you are or will be breast-feeding while you use Amino-Cerv Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Amino-Cerv Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Amino-Cerv Cream. Seek medical attention right away if any of these SEVERE side effects occur:

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.

See also: Amino-Cerv 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 Amino-Cerv Cream:

Store Amino-Cerv Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amino-Cerv Cream out of the reach of children and away from pets.

General information: If you have any questions about Amino-Cerv Cream, please talk with your doctor, pharmacist, or other health care provider. Amino-Cerv Cream 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 Amino-Cerv Cream. 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 Amino-Cerv resources Amino-Cerv Side Effects (in more detail)Amino-Cerv Use in Pregnancy & BreastfeedingAmino-Cerv Support Group0 Reviews for Amino-Cerv - Add your own review/rating Compare Amino-Cerv with other medications Cervicitis
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Urea Cycle Disorders Medications


Drugs associated with Urea Cycle Disorders

The following drugs and medications are in some way related to, or used in the treatment of Urea Cycle Disorders. 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: Buphenyl
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Nutraplus Cream


1. Name Of The Medicinal Product

Nutraplus Cream

2. Qualitative And Quantitative Composition

Urea 10% w/w

For excipients see section 6.1

3. Pharmaceutical Form

Cream

Smooth white, almost odourless cream (water in oil emulsion).

4. Clinical Particulars 4.1 Therapeutic Indications

An emollient, moisturising and protective cream for the treatment of dry or damaged skin.

4.2 Posology And Method Of Administration

Adults, elderly and children

Apply evenly to the dry skin areas two to three times daily, or as directed by the physician or pharmacist.

4.3 Contraindications

None

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes. If irritation occurs, discontinue use temporarily.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

No known effects. Use at the discretion of the physician or pharmacist.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None known.

4.9 Overdose

Not applicable

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Urea is a recognised hydrating agent that has been widely used topically to treat dry or damaged skin.

5.2 Pharmacokinetic Properties

Not applicable. Nutraplus is a topical (cutaneous) preparation.

5.3 Preclinical Safety Data

No specific information is presented given the widespread use of topically applied urea on humans over many years.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol monostearate

Octyl palmitate

Myristyl lactate

Mineral oil

Promulgen D (contains Cetearyl alcohol and ceteareth-20)

Propylene glycol

Propyl parahydroxybenzoate (E216)

Methyl parahydroxybenzoate (E218)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Thirty six months.

6.4 Special Precautions For Storage

Do not store above 25oC.

As with all medicines, Nutraplus Cream should be stored out of the sight and reach of children.

6.5 Nature And Contents Of Container

White, polyethylene tube with a white polypropylene screw cap as the closure.

Pack sizes: 60g and 100g

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

8. Marketing Authorisation Number(S)

PL 10590/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

4 June 1991

10. Date Of Revision Of The Text

February 2006


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Aluvea


urea
Dosage Form: cream
Aluvea

(39% Urea Cream)

RX ONLY

Aluvea Description

Aluvea™ (urea) cream, 39% is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin.

Each gram of Aluvea Cream contains 39% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax NF, glycerin 99.7% USP, isopropyl myristate, purified water, sorbitol 70% Solution USP, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate.

CHEMICAL STRUCTURE

Urea is diamide of Carbonic acid with the following structure:

Aluvea - Clinical Pharmacology

Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

PHARMACOKINETICS

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

INDICATION AND USAGE

Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

Contraindications

Known hypersensitivity to any of the listed ingredients

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

Urea should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use.

Pregnancy Category C

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

Nursing Mothers

It is not known whether Aluvea is excreted in human milk, therefore caution should be exercised when administering to a nursing mother.

Adverse Reactions

Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.

DOSAGE AND ADMINISTRATIONS

Apply Aluvea to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.

KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN How is Aluvea Supplied

Aluvea is supplied in an 8oz. bottle.

NDC 0259-1139-80

Store at room temperature 15°C -30°C (59°F-86°F).

Protect from freezing.

Manufactured for:
Merz Pharmaceuticals, LLC
Greensboro, NC 27410

5011457 12/10

PRINCIPAL DISPLAY PANEL - 227g Carton

NDC 0259-1139-80

Aluvea™
39% Urea Cream

WITH UNIQUE
CSP ™
VEHICLE
TECHNOLOGY

FOR EXTERNAL USE ONLY

8 oz. (227g)

Rx ONLY


Aluvea 
urea  cream Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0259-1139 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (Urea) Urea 39 g  in 100 g Inactive Ingredients Ingredient Name Strength Dimethyl isosorbide   Glycerin   Isopropyl Myristate   Sorbitol   Tridecyl Stearate   Neopentyl Glycol Dicaprate   Tridecyl Trimellitate   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0259-1139-80 1 BOTTLE In 1 CARTON contains a BOTTLE 1 227 g In 1 BOTTLE This package is contained within the CARTON (0259-1139-80)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/15/2011
Labeler - Merz Pharmaceuticals, LLC (126209282) Establishment Name Address ID/FEI Operations Crown Laboratories, Inc. 079035945 MANUFACTURE Revised: 04/2011Merz Pharmaceuticals, LLC More Aluvea resources Aluvea Side Effects (in more detail) Aluvea Use in Pregnancy & Breastfeeding Aluvea Support Group 0 Reviews for Aluvea - 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 Aluvea with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Calmurid Cream


UREA 10% LACTIC ACID 5%

Calmurid

1 0%/ 5% W/W CREAM

Calmurid 10%/ 5% w/w Cream

Urea 10% w/w

Lactic Acid 5% w/w

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Calmurid carefully to get the best results from it.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

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

What Calmurid is and what it is used for Your doctor or pharmacist has recommended this cream for use as a moisturising cream for the treatment of dry, rough, scaly skin such as eczema and similar conditions. The active substances in Calmurid are urea and lactic acid which act as moisturisers. This helps make your skin soft and supple. Before you use Calmurid Do not use Calmurid if you are: Allergic (hypersensitive) to urea or lactic acid or any of the other ingredients of Calmurid. Please check by reading the list of ingredients in section 6. If you answer yes, you must inform your doctor before starting treatment.

Please seek immediate medical attention if you experience symptoms of an allergic reaction. Signs or symptoms of a severe allergic reaction may include a rash, with or without itching, swelling of the face, eyelids or lips and difficulty in breathing.

Take special care with Calmurid Avoid contact with the eyes, eyelids, lips and other mucous surfaces. Upon accidental contact, rinse the affected area with clean water. Calmurid may cause stinging if applied to damaged skin (raw cracked areas or cracked skin) or sensitive areas of the body such as the mouth or nostrils. Using other medicines This cream might affect other medicines that you apply to your skin. Tell your doctor or pharmacist if you are using other medicines in this way.

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

Pregnancy and breast-feeding

You should not use Calmurid and tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding.

Your doctor will then decide whether you should use Calmurid.

Ask your doctor or pharmacist for advice before taking any medicine.

Please read the back of this leaflet

How to use Calmurid

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

Calmurid Cream is for EXTERNAL USE ONLY. First gently wash and dry the affected areas of your skin. Apply a thick layer over the affected areas. Do not rub it in yet. Leave it on your skin for 3 to 5 minutes, then rub it in gently. Wipe off any excess cream with a tissue (do not wash it off). The cream should be used in this way twice a day, or as advised by your doctor. If you need to use Calmurid on your feet, soak them in water for 15 minutes and then dry them with a rough towel before use. How long you will have to use this product will depend on how quickly your condition improves. Always seek the advice of your doctor or pharmacist. If you use more Calmurid than you should or accidentally swallow any of the cream

If you use too much Calmurid and stinging occurs, wash the cream off with water.

In the rare event that you accidentally swallow any of this product, seek medical advice.

If you forget to use Calmurid

Do not worry if you forget to use your cream at the right time. When you remember, start using the product again as you did before.

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

Calmurid Cream Side Effects

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

Effects on the skin Calmurid may cause stinging if applied to raw areas or cracks in the skin or the lips. Keep Calmurid away from other sensitive areas of your body. If stinging occurs, wash the cream off with water. Should stinging be a problem, you can mix it with an equal amount of Aqueous Cream BP (ask your pharmacist for this) for a week, after which it would be alright to use the cream on its own again, but you must consult your doctor or pharmacist first.

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 Calmurid Keep out of the reach and sight of children. Do not use Calmurid after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate or freeze.

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 Calmurid contains Calmurid contains the active substances urea 100mg/g and lactic acid 50mg/g. The other ingredients are glyceryl monostearate, betaine monohydrate, diethanolamine cetyl phosphate, hard fat, cholesterol, sodium chloride and purified water. What Calmurid looks like and contents of the pack

Calmurid is a white cream. It is available in 15 g, 20 g, 30 g, 50g and 100 g tubes and in 400 g and 500 g pump dispensers, either on prescription from your doctor or indirectly from your pharmacist.

Not all sizes of the tube may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Galderma (UK) Limited Meridien House 69-71 Clarendon Road Watford Herts WD17 1DS UK

Manufacturer:

Laboratoires Galderma ZI-Montd?sir 74540 Alby-sur-Ch?ran France

Marketing Authorisation Numbers: PL 10590/0009 (UK), PA 590/8/1 (IRE)

This leaflet was last approved in 04/2009.

P20615-10


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Boots Lip and Cold Sore Cream


Boots Lip and Cold Sore Cream

Relieves cracked lips and cold sores

5 g

Read all of this carton for full instructions.

What this medicine is for

An antibacterial and protective cream for cracked lips and cold sores.

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Adults and children: Use a very small amount on the affected area every hour, when you need to.

Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor.

Possible side effects

Cetostearyl alcohol may cause skin reactions (e.g. contact dermatitis).

If this becomes severe, or you notice any side effect, please tell your pharmacist or doctor.

How to store this medicine

Store below 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

This cream contains Cetrimide 0.5% w/w, Chlorocresol 0.1% w/w, Dimeticone 9% w/w, Urea 1% w/w.

Also contains: deionised water, liquid paraffin, cetostearyl alcohol.

PL 30306/0028

Text prepared 8/07

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

CCS Clean Chemicals Sweden AB Borl?nge SE 78173 Sweden Marketing Authorisation held by Actavis Group PTC ehf Reykjv?kurvegi 76 – 78 220 Hafnarfjorur Iceland

If you need more advice ask your pharmacist .

2787bXPil


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Gordons Urea 40


Generic Name: urea
Dosage Form: ointment
Gordons Urea 40

Urea 40% has been used for many years for the nonsurgical avulsion of mycotic nails. Nonsurgical avulsion is a conservative procedure which can be utilized by the geriatric, diabetic or vascular patient. Nonsurgical avulsion has the advantage of avoiding the possible side effects of oral drugs.


Gordon's Urea 40% is supplied as 1 oz. Jars.

Urea 40%, Petrolatum 17.8%, White Wax 5%, Anhydrous Lanolin 15%, Purified Water

For loosening, debriding and avulsion of devitalized nail tissue. Apply to affected area in an apertured pad. Protect surrounding skin. Apply Urea 40% to the diseased nail surface and cover with plastic film. Anchor with adhesive tape. Cover with "finger cut" of plastic or vinyl glove and anchor with more adhesive tape. Keep dry and occlusive for 3-7 days. Cleanse, debride and reapply if necessary.


Hypersensitivity to Urea or any of the components of this preparation. If redness or irritation occurs, discontinue use. For external use only. Keep out of reach of children.

Urea is an organic compound present in mammals. Wehn it was first synthesized from an inorganic compound in the last century. Urea is now prepared by heating Calcium Cyanamide with water under pressure. Proteolytic action on the nail plate and nail bed by its keratolytic properties, with the resulting maceration inducing an effective, painless and bloodless nail removal procedure.


Gordons Urea 40  
urea  ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10481-3005 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (Urea) Urea 0.4 g  in 1 g Inactive Ingredients Ingredient Name Strength Water   PETROLATUM   LANOLIN   WHITE WAX   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10481-3005-1 30 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/16/2010
Labeler - Gordon Laboratories (002333847) Registrant - Gordon Laboratories (002333847) Establishment Name Address ID/FEI Operations Gordon Laboratories 002333847 manufacture Revised: 07/2010Gordon Laboratories
More Gordons Urea 40 resources Gordons Urea 40 Use in Pregnancy & Breastfeeding Gordons Urea 40 Support Group 9 Reviews for Gordons Urea 40 - Add your own review/rating Compare Gordons Urea 40 with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Gynazole-1 Cream


Pronunciation: byoo-toe-KOE-na-zole
Generic Name: Butoconazole
Brand Name: Gynazole-1
Gynazole-1 Cream is used for:

Treating vaginal yeast infections.

Gynazole-1 Cream is an antifungal agent. It works by weakening the cell wall of sensitive fungi, causing the cell contents to leak. This kills the fungi.

Do NOT use Gynazole-1 Cream if: you are allergic to any ingredient in Gynazole-1 Cream

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

Before using Gynazole-1 Cream:

Some medical conditions may interact with Gynazole-1 Cream. 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 Gynazole-1 Cream. However, no specific interactions with Gynazole-1 Cream are known at this time.

Ask your health care provider if Gynazole-1 Cream 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 Gynazole-1 Cream:

Use Gynazole-1 Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Gynazole-1 Cream is for vaginal use only. Do not use in the eyes or take by mouth. Wash your hands before and after using Gynazole-1 Cream. Insert 1 applicator-full of cream into the vagina. Throw the applicator away after using it. Only one dose of Gynazole-1 Cream is required. If you forget to use Gynazole-1 Cream, use it as soon as you remember.

Ask your health care provider any questions you may have about how to use Gynazole-1 Cream.

Important safety information: If your symptoms do not get better within a few days or if they get worse, check with your doctor. If your infection clears up and occurs again in a few weeks, see your doctor. Recurrent vaginal infections, especially those that are difficult to cure, may be an early sign of HIV infection in women who are considered at risk for HIV infection. Gynazole-1 Cream may be used during your period. Use a sanitary pad rather than a tampon to prevent staining of clothing. Gynazole-1 Cream contains mineral oil, which may weaken latex or rubber products such as condoms and diaphragms. Do not use condoms or diaphragms within 72 hours of using Gynazole-1 Cream. Gynazole-1 Cream 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 Gynazole-1 Cream while you are pregnant. It is not known if Gynazole-1 Cream is found in breast milk. If you are or will be breast-feeding while you use Gynazole-1 Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Gynazole-1 Cream:

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:

Burning, itching, soreness, or swelling in or around the vagina not present before using Gynazole-1 Cream.

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); pain or cramping in the stomach or pelvic area.

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: Gynazole-1 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. Gynazole-1 Cream may be harmful if swallowed.

Proper storage of Gynazole-1 Cream:

Store Gynazole-1 Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Gynazole-1 Cream out of the reach of children and away from pets.

General information: If you have any questions about Gynazole-1 Cream, please talk with your doctor, pharmacist, or other health care provider. Gynazole-1 Cream 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 Gynazole-1 Cream. 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 Gynazole-1 resources Gynazole-1 Side Effects (in more detail) Gynazole-1 Use in Pregnancy & Breastfeeding Gynazole-1 Support Group 2 Reviews for Gynazole-1 - Add your own review/rating Compare Gynazole-1 with other medications Vaginal Yeast Infection
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X-Viate Gel


urea
Dosage Form: gel
X-VIATE™ 40% CREAM
(Urea 40% in a cream base)
X-VIATE™ 40% LOTION
(Urea 40% in a lotion base)
X-VIATE™ 40% GEL
(Urea 40% in a gel base)

Rx only

For external use only.

Not for ophthalmic use.

X-Viate Gel Description

X-VIATE™ is a potent keratolytic emollient which is a gentle tissue softener for skin and/or nails.

Each gram of X-VIATE™ 40% CREAM contains 40% Urea in a cream base of Carbopol, Cetyl Alcohol, Glyceryl Monostearate, Light Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, White Petrolatum and Xanthan Gum.

Each gram of X-VIATE™ 40% LOTION contains 40% Urea in a lotion base of Carbopol, Cetyl Alcohol, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Propyl Paraben, Propylene Glycol, Purified Water, Trolamine, White Petrolatum and Xanthan Gum.

Each gram of X-VIATE™ 40% GEL contains 40% Urea in a gel base of Hydroxyethyl Cellulose, Methyl Paraben, Propylene Glycol and Purified Water.

CHEMISTRY

Urea is a diamide of carbonic acid with the following chemical structure:

X-Viate Gel - Clinical Pharmacology

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS

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

INDICATIONS AND USES:

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

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

PREGNANCY Pregnancy Category B

Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, X-VIATE™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 X-VIATE™ is administered to a nursing woman.

Adverse Reactions

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

X-Viate Gel Dosage and Administration

Apply X-VIATE™ to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.

How is X-Viate Gel Supplied

X-VIATE™ 40% CREAM (40% Urea) is supplied in:

28.5g (1 oz) tube 58980-625-10 85g (3 oz) tube 58980-625-30 199g (7 oz) tube 58980-625-70

X-VIATE™ 40% LOTION (40% Urea) is supplied in:

237mL (8 oz) bottle 58980-623-80

X-VIATE™ 40% GEL (40% Urea) is supplied in:

15mL bottle 58980-624-15

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

Distributed by:
Stratus Pharmaceuticals Inc,
Miami, Florida 33186-6727
Toll free: 800-442-7882
www.stratuspharmaceuticals.com

Manufactured by:
Sonar Products, Inc., Carlstadt, NJ 07072

PG-KVG-IN 2009-0608

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

X-VIATE 40% GEL

NDC 58980-624-15

X-VIATE™
40% GEL

Gentle, potent,
tissue softener,
for nail and skin

Rx only

UREA 40%
IN A GEL BASE

Distributed by
STRATUS

NET WT 15 mL Bottle
with Applicator Brush


X-VIATE 
urea  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58980-624 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (Urea) Urea 6.726 g  in 15 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400   Methylparaben   Water   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 58980-624-15 1 VIAL In 1 BOX contains a VIAL, GLASS 1 15 mL In 1 VIAL, GLASS This package is contained within the BOX (58980-624-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/03/2006
Labeler - Stratus Pharmaceuticals, Inc (789001641) Establishment Name Address ID/FEI Operations Sonar Products Inc 104283945 MANUFACTURE Revised: 10/2011Stratus Pharmaceuticals, Inc More X-Viate Gel resources X-Viate Gel Side Effects (in more detail)X-Viate Gel Use in Pregnancy & BreastfeedingX-Viate Gel Support Group2 Reviews for X-Viate - Add your own review/rating Compare X-Viate Gel with other medications Dermatological DisordersDry SkinPityriasis rubra pilaris
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Kerasal


Generic Name: salicylic acid and urea topical (sal ih SILL ik AH sid and you REE ah)
Brand Names: Kerasal

What is Kerasal (salicylic acid and urea topical)?

Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin.

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

Salicylic acid and urea topical is used to soften rough, scaly skin and calluses on the feet.

Salicylic acid and urea topical may also be used for purposes other than those listed here.

What is the most important information I should know about Kerasal (salicylic acid and urea topical)? Do not use salicylic acid and urea topical on other areas or for purposes other than those directed on the package or by your doctor. What should I discuss with my healthcare provider before using Kerasal (salicylic acid and urea topical)? Do not use salicylic acid and urea topical on other areas or for purposes other than those directed on the package or by your doctor. It is not known whether salicylic acid and urea topical will be harmful to an unborn baby. Do not use salicylic acid and urea topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether salicylic acid and urea topical passes into breast milk. Do not use salicylic acid and urea topical without first talking to your doctor if you are breast-feeding a baby. How should I use Kerasal (salicylic acid and urea topical)?

Use salicylic acid and urea topical exactly as directed by your healthcare provider or as directed on the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Gently clean and dry the affected area.

Apply the medication to the affected area(s) as directed.

It is important to use salicylic acid and urea topical regularly to get the most benefit. Do not stop using the medication if you do not see results immediately. Use the medication for the full amount of time directed. Store salicylic acid and urea topical at room temperature away from moisture and heat. What happens if I miss a dose?

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

Do not apply a double dose of the medication.

What happens if I overdose? An overdose of salicylic acid and urea topical is unlikely to be harmful. If you do suspect an overdose, or if the medication has been ingested, call a poison control center or emergency room for advice. What should I avoid while using Kerasal (salicylic acid and urea topical)?

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. Other topical products may interfere with treatment or cause skin irritation.

Kerasal (salicylic acid and urea topical) side effects Serious side effects are expected to occur with the use of salicylic acid and urea topical. If you do experience any of the following rare serious side effects, stop using salicylic acid and urea topical and seek emergency medical attention or contact your doctor:

an rare but serious allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives); or

severe skin irritation.

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

What other drugs will affect Kerasal (salicylic acid and urea topical)?

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. Other topical products may interfere with treatment or cause skin irritation.

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

More Kerasal resources Kerasal Side Effects (in more detail) Kerasal Use in Pregnancy & Breastfeeding Kerasal Drug Interactions Kerasal Support Group 0 Reviews for Kerasal - Add your own review/rating Salvax Duo Foam MedFacts Consumer Leaflet (Wolters Kluwer) Salvax Duo Plus Foam MedFacts Consumer Leaflet (Wolters Kluwer) Compare Kerasal with other medications Foot Care Where can I get more information? Your pharmacist has additional information about salicylic acid and urea topical written for health professionals that you may read.

See also: Kerasal side effects (in more detail)


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Hydromol Intensive


1. Name Of The Medicinal Product

Hydromol Intensive

2. Qualitative And Quantitative Composition

Hydromol Intensive contains urea Ph Eur 10% w/w.

3. Pharmaceutical Form

A smooth, unperfumed, non greasy, off white cream for topical administration.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of ichthyosis and hyperkeratotic skin conditions associated with atopic eczema, xeroderma, iasteatosis and other chronic dry skin conditions.

4.2 Posology And Method Of Administration

Hydromol Intensive is applied topically. Wash affected areas well, rinse off all traces of soap, dry, and apply sparingly twice daily. Occlusive dressings may be used but are usually unnecessary because of the self-occlusive nature of the cream.

4.3 Contraindications

Known hypersensitivity to the product.

4.4 Special Warnings And Precautions For Use

Avoid application to moist or broken skin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Hydromol Intensive may increase the penetration through the skin barrier of other topically applied medicaments.

4.6 Pregnancy And Lactation

Animal reproduction studies have not been conducted with Hydromol Intensive. Hydromol Intensive should only be used if the anticipated benefits outweigh the risks.

4.7 Effects On Ability To Drive And Use Machines

Hydromol Intensive does not interfere with the ability to drive or use machines.

4.8 Undesirable Effects

May produce local irritations (including erythema, burning or pruritus) and oedema when applied to sensitive, moist or fissured skin.

4.9 Overdose

Topical applications of excessive amounts of Hydromol Intensive might cause skin irritation but no other effects would be expected. Ingestion of a large amount of Hydromol Intensive would be expected to result in gastrointestinal irritation (nausea and vomiting). Symptomatic and supportive care should be given. Liberal oral administration of milk or water may be helpful.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Urea has a therapeutic effect in chronic dry skin conditions through its hydrating, keratolytic and anti-pruritic properties.

5.2 Pharmacokinetic Properties

There is no information available on the pharmacokinetics of urea.

6. Pharmaceutical Particulars 6.1 List Of Excipients

The cream also contains white soft paraffin, maize starch, isopropyl myristate, syncrowax HR-C, palmitic acid, sorbitan laurate and arlatone G.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Store below 30°C.

6.5 Nature And Contents Of Container

Hydromol Intensive is available in tubes of 30g and 100g.

6.6 Special Precautions For Disposal And Other Handling

A patient leaflet is provided with details of use and handling of the product.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8. Marketing Authorisation Number(S)

PL 16853/0061

9. Date Of First Authorisation/Renewal Of The Authorisation

10 September 1991

10. Date Of Revision Of The Text

5th December 2008


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Salicylic Acid/Urea/White Petrolatum Ointment


Pronunciation: SAL-i-SIL-ik AS-id/ue-REE-a/PET-roe-LAY-tum
Generic Name: Salicylic Acid/Urea/White Petrolatum
Brand Name: Generic only. No brands available.
Salicylic Acid/Urea/White Petrolatum Ointment is used for:

Treating dry, scaly, or callused skin.

Salicylic Acid/Urea/White Petrolatum Ointment is a keratolytic and debriding combination. It works by breaking down dead skin and softening the skin.

Do NOT use Salicylic Acid/Urea/White Petrolatum Ointment if: you are allergic to any ingredient in Salicylic Acid/Urea/White Petrolatum Ointment

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

Before using Salicylic Acid/Urea/White Petrolatum Ointment:

Some medical conditions may interact with Salicylic Acid/Urea/White Petrolatum Ointment. 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 diabetes

Some MEDICINES MAY INTERACT with Salicylic Acid/Urea/White Petrolatum Ointment. Because little, if any, of Salicylic Acid/Urea/White Petrolatum Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Salicylic Acid/Urea/White Petrolatum Ointment 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 Salicylic Acid/Urea/White Petrolatum Ointment:

Use Salicylic Acid/Urea/White Petrolatum Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wash your hands before using Salicylic Acid/Urea/White Petrolatum Ointment. Wash the affected area with mild soap and warm water. Allow your skin to dry before applying the medicine. Gently massage the medicine in to the affected area as directed by your doctor or the package labeling. Wash your hands immediately after using Salicylic Acid/Urea/White Petrolatum Ointment, unless your hands are part of the treated area. If you miss a dose of Salicylic Acid/Urea/White Petrolatum Ointment, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Salicylic Acid/Urea/White Petrolatum Ointment.

Important safety information: Salicylic Acid/Urea/White Petrolatum Ointment is for external use only. Do not get it in your eyes, on your lips, or on the inside of your nose or mouth. If you get Salicylic Acid/Urea/White Petrolatum Ointment in any of these areas, rinse right away with cool water. Do not apply Salicylic Acid/Urea/White Petrolatum Ointment to open wounds or to broken, irritated, or infected skin. Talk with your doctor before you use any other medicines or cleansers on your skin. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Salicylic Acid/Urea/White Petrolatum Ointment while you are pregnant. It is not known if Salicylic Acid/Urea/White Petrolatum Ointment is found in breast milk. If you are or will be breast-feeding while you use Salicylic Acid/Urea/White Petrolatum Ointment, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Salicylic Acid/Urea/White Petrolatum Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Salicylic Acid/Urea/White Petrolatum Ointment. 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); excessive burning, itching, irritation, peeling, redness, or tenderness of your skin.

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. Salicylic Acid/Urea/White Petrolatum Ointment may be harmful if swallowed.

Proper storage of Salicylic Acid/Urea/White Petrolatum Ointment:

Store Salicylic Acid/Urea/White Petrolatum Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Keep Salicylic Acid/Urea/White Petrolatum Ointment out of the reach of children and away from pets.

General information: If you have any questions about Salicylic Acid/Urea/White Petrolatum Ointment, please talk with your doctor, pharmacist, or other health care provider. Salicylic Acid/Urea/White Petrolatum Ointment 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 Salicylic Acid/Urea/White Petrolatum Ointment. 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 Salicylic Acid/Urea/White Petrolatum resources Salicylic Acid/Urea/White Petrolatum Use in Pregnancy & Breastfeeding Salicylic Acid/Urea/White Petrolatum Drug Interactions Salicylic Acid/Urea/White Petrolatum Support Group 0 Reviews for Salicylic Acid/Urea/White Petrolatum - Add your own review/rating Compare Salicylic Acid/Urea/White Petrolatum with other medications Foot Care
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Monistat 7 Cream



Dosage Form: vaginal cream
Monistat 7 Cream

Drug Facts

Active ingredient

Miconazole nitrate 2% (100 mg in each applicatorful)

Purpose

Vaginal antifungal

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product, read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritate skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor Other information

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol Questions?

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL - 45g Tube Carton

NDC 30014-024-15

MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 100 mg per application)

CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

7 Day Vaginal Cream
with Disposable Applicators

Net Wt.
1.59 oz. (45g) tube


MONISTAT 7   7-DAY DISPOSABLE APPLICATORS
miconazole nitrate  cream Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-024 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 30014-024-15 7 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 45 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (30014-024-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/15/2010
Labeler - McNeil-PPC, Inc. (801375143) Revised: 04/2010McNeil-PPC, Inc.
More Monistat 7 Cream resources Monistat 7 Cream Use in Pregnancy & Breastfeeding Monistat 7 Cream Drug Interactions Monistat 7 Cream Support Group 8 Reviews for Monistat 7 - Add your own review/rating Compare Monistat 7 Cream with other medications Cutaneous Candidiasis Oral Thrush Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Urea Topical Suspension


Pronunciation: ue-REE-a/SOE-dee-um HYE-al-ure ON-ate
Generic Name: Urea
Brand Name: Umecta PD
Urea Topical Suspension is used for:

Promoting the healing of certain skin conditions (eg, hyperkeratotic conditions). It may also be used for certain other skin conditions (eg, corns; calluses; rough, dry skin) as determined by your doctor.

Urea Topical Suspension contains a debriding agent and an emollient. The debriding agent works by helping the breakdown of dead skin and pus, which helps to loosen and shed hard and scaly skin. The emollient moisturizes and softens the skin.

Do NOT use Urea Topical Suspension if: you are allergic to any ingredient in Urea Topical Suspension

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

Before using Urea Topical Suspension:

Some medical conditions may interact with Urea Topical Suspension. 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 Urea Topical Suspension. Because little, if any, of Urea Topical Suspension is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Urea Topical Suspension 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 Urea Topical Suspension:

Use Urea Topical Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Urea Topical Suspension is for external use only. Wash hands before and after using Urea Topical Suspension, unless your hands are part of the treated area. Shake well before each use. Apply a small amount of Urea Topical Suspension to the affected area as directed by your doctor. Gently rub in until it is evenly distributed. If you get Urea Topical Suspension on any skin that is not part of the treated area, wash it off thoroughly. You may cover the affected area unless directed otherwise by your doctor. If you miss a dose of Urea Topical Suspension, 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 Urea Topical Suspension.

Important safety information: Urea Topical Suspension is for external use only. Do not get it in your eyes, nose, or mouth. If you get Urea Topical Suspension in your eyes, rinse them immediately with a generous amount of cool water. Do not apply to broken or severely irritated skin. Do not exceed the recommended dose, use Urea Topical Suspension for longer than prescribed, or use Urea Topical Suspension for other skin conditions without checking with your doctor. Urea Topical Suspension 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. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Urea Topical Suspension, contact your doctor. You will need to discuss the benefits and risks of using Urea Topical Suspension during pregnancy. It is not known if Urea Topical Suspension is found in breast milk after topical use. If you are or will be breast-feeding while you use Urea Topical Suspension, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Urea Topical Suspension:

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, stinging, or itching.

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 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 Urea Topical Suspension:

Store Urea Topical Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Protect from freezing. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Urea Topical Suspension out of the reach of children and away from pets.

General information: If you have any questions about Urea Topical Suspension, please talk with your doctor, pharmacist, or other health care provider. Urea Topical Suspension 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 Urea Topical Suspension. 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 Urea resources Urea Use in Pregnancy & Breastfeeding Urea Support Group 9 Reviews for Urea - Add your own review/rating Compare Urea with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Papain/Urea/Chlorophyllin Ointment


Pronunciation: pap-ANE/you-REE-ah/KLOR-oh-FILL-in
Generic Name: Papain/Urea/Chlorophyllin
Brand Name: Examples include Panafil and Ziox
Papain/Urea/Chlorophyllin Ointment is used for:

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

Papain/Urea/Chlorophyllin Ointment 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 Ointment if: you are allergic to any ingredient in Papain/Urea/Chlorophyllin Ointment

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

Before using Papain/Urea/Chlorophyllin Ointment:

Some medical conditions may interact with Papain/Urea/Chlorophyllin Ointment. 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 Ointment. 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 Ointment's effectiveness

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

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

Papain/Urea/Chlorophyllin Ointment is for external use only. Before each use of Papain/Urea/Chlorophyllin Ointment, clean the affected area with saline or another mild wound cleansing solution. Do not use hydrogen peroxide. Apply Papain/Urea/Chlorophyllin Ointment directly to the lesion, cover with appropriate dressing (eg, bandages), and secure into place. Wash the lesion each time the dressing is changed. 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 Ointment, 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 Ointment.

Important safety information: Papain/Urea/Chlorophyllin Ointment is for external use only. Do not get it in the eyes or mouth. If you get Papain/Urea/Chlorophyllin Ointment in the eyes, rinse them immediately 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 Ointment while you are pregnant. It is not known if Papain/Urea/Chlorophyllin Ointment is found in breast milk. If you are or will be breast-feeding while you use Papain/Urea/Chlorophyllin Ointment, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Papain/Urea/Chlorophyllin Ointment:

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 Ointment:

Store Papain/Urea/Chlorophyllin Ointment at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Papain/Urea/Chlorophyllin Ointment out of the reach of children and away from pets.

General information: If you have any questions about Papain/Urea/Chlorophyllin Ointment, please talk with your doctor, pharmacist, or other health care provider. Papain/Urea/Chlorophyllin Ointment 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 Ointment. 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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Urea Ointment



Kylemore 50% Urea Ointment DESCRIPTION:

Kylemore 50% Urea Ointment is a keratolytic emollient, which is a gentle, yet potent, tissue softener for skin. Each gram of Kylemore 50% Urea Ointment contains 50% Urea, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Edetate Disodium, Glycerin, Hydroxyethylcellulose, Lactic Acid, Linoleic Acid, PEG-6, Polysorbate 60, Propylene Glycol, Purified Water, Sorbitan Stearate, Tocopherol (Vitamin E), Triethanolamine, Xanthan Gum, and Zinc Pyrithione.
Urea is a diamide of carbonic acid with the following chemical structure:

CLINICAL PHARMACOLOGY:

Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS:

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

INDICATIONS AND USES:

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

CONTRAINDICATIONS:

Known hypersensitivity to any of the listed ingredients.

WARNINGS:

For external use only. Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS:

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 B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Kylemore 50% Urea Ointment should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Kylemore 50% Urea Ointment is administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
ADVERSE REACTIONS:

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

DOSAGE AND ADMINISTRATION: Apply Kylemore 50% Urea Ointment to affected skin twice per day, or as directed by a physician.
HOW SUPPLIED: Kylemore 50% Urea Ointment is supplied as a 45g (1.5 oz) tube, NDC 68032-130-45.
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
Manufactured for:
Kylemore Pharmaceuticals
Suwanee, GA 30024
Rev. 12/09 130-10 PACKAGING:

Kylemore 50% Urea Ointment carton:


UREA 
urea  ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49769-130 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 500 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 49769-130-45 45 g In 1 TUBE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010
Labeler - Kylemore Pharmaceuticals, LLC (831892471) Revised: 01/2010Kylemore Pharmaceuticals, LLC
More Urea Ointment resources Urea Ointment Use in Pregnancy & Breastfeeding Urea Ointment Support Group 9 Reviews for Urea - Add your own review/rating Compare Urea Ointment with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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Urea Cloths


Pronunciation: ue-REE-a
Generic Name: Urea
Brand Name: Kerol Redi Cloths
Urea Cloths are used for:

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

Urea Cloths are 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 Urea Cloths if: you are allergic to any ingredient in Urea Cloths

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

Before using Urea Cloths:

Some medical conditions may interact with Urea Cloths. 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 Urea Cloths. Because little, if any, of Urea Cloths are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Urea Cloths 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 Urea Cloths:

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

Wash your hands immediately before and after using Urea Cloths unless your hands are part of the treated area. Gently apply Urea Cloths to the affected skin as directed by your doctor. If you miss a dose of Urea Cloths 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 Urea Cloths.

Important safety information: Urea Cloths are for external use only. Do not get it in your eyes, nose, mouth, or on your lips. If you get Urea Cloths 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 Urea Cloths for other skin conditions at a later time. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Urea Cloths while you are pregnant. It is not known if Urea Cloths are found in breast milk. If you are or will be breast-feeding while you use Urea Cloths, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Urea Cloths:

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.

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 Urea Cloths:

Store Urea Cloths at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Keep Urea Cloths out of the reach of children and away from pets.

General information: If you have any questions about Urea Cloths, please talk with your doctor, pharmacist, or other health care provider. Urea Cloths are 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 Urea Cloths. 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 Urea resources Urea Use in Pregnancy & Breastfeeding Urea Support Group 9 Reviews for Urea - Add your own review/rating Aluvea Prescribing Information (FDA) Kerafoam Prescribing Information (FDA) Kerafoam 42 Prescribing Information (FDA) Kerol AD Prescribing Information (FDA) Latrix Prescribing Information (FDA) Remeven Prescribing Information (FDA) Ultra Mide Topical Advanced Consumer (Micromedex) - Includes Dosage Information Umecta Mousse Prescribing Information (FDA) Umecta Nail Film Prescribing Information (FDA) Umecta PD Prescribing Information (FDA) Urea Nail Gel Prescribing Information (FDA) Urealac Prescribing Information (FDA) X-Viate Prescribing Information (FDA) Compare Urea with other medications Dermatological Disorders Dry Skin Pityriasis rubra pilaris
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sodium sulfacetamide and urea topical


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

What is sodium sulfacetamide and urea topical?

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

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

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

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

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

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

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

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

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

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

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

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

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

What happens if I overdose?

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

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

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

Sodium sulfacetamide and urea topical Dosing Information

Usual Adult Dose for Secondary Cutaneous Bacterial Infections:

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

Usual Adult Dose for Dandruff:

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

Usual Adult Dose for Seborrheic Dermatitis:

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

Usual Pediatric Dose for Secondary Cutaneous Bacterial Infections:

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

Usual Pediatric Dose for Dandruff:

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

Usual Pediatric Dose for Seborrheic Dermatitis:

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

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

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

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


Generic Name: nystatin (Vaginal route)

nye-STAT-in

Commonly used brand name(s)

In Canada

Mycostatin Mycostatin Vaginal Cream Nadostine Nilstat Vaginal Cream Nilstat Vaginal Tablet Nyaderm Vaginal Cream

Available Dosage Forms:

Cream Tablet

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Mycostatin Vaginal Cream

Nystatin belongs to the group of medicines called antifungals. Vaginal nystatin is used to treat fungus infections of the vagina. Nystatin vaginal cream or tablets may also be used for other problems as determined by your doctor.

Nystatin is available only with your doctor's prescription.

Before Using Mycostatin Vaginal Cream

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

Studies on this medicine have been done only in adults, and there is no specific information comparing use of vaginal nystatin in children with use in other age groups.

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 or if they cause different side effects or problems in older people. There is no specific information comparing the use of vaginal nystatin in the elderly with use in other age groups.

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.

Proper Use of nystatin

This section provides information on the proper use of a number of products that contain nystatin. It may not be specific to Mycostatin Vaginal Cream. Please read with care.

Nystatin usually comes with patient directions. Read them carefully before using this medicine.

This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator to insert the vaginal tablet.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Also, keep using this medicine even if you begin to menstruate during the time of treatment. Do not miss any doses.

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 treating fungus (yeast) infections: For vaginal cream dosage form: Adults and teenagers—One 100,000-unit applicatorful inserted into the vagina one or two times a day for two weeks. Or, your doctor may want you to insert one 500,000-unit applicatorful into the vagina once a day. Children—Dose must be determined by your doctor. For vaginal tablet dosage form: Adults and teenagers—One 100,000-unit tablet inserted into the vagina one or two times a day for two weeks. Children—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 Mycostatin Vaginal Cream

To help cure the infection and to help prevent reinfection, good health habits are required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon, rayon) underclothes. Wear freshly laundered underclothes.

If you have any questions about this, check with your health care professional.

If you have any questions about douching or intercourse during the time of treatment with nystatin, check with your doctor.

Since there may be some vaginal drainage while you are using this medicine, a sanitary napkin may be worn to protect your clothing.

Mycostatin Vaginal Cream 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:

Rare Vaginal burning or itching not present before use of this medicine

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.

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 Mycostatin Vaginal Cream resources Mycostatin Vaginal Cream Use in Pregnancy & BreastfeedingMycostatin Vaginal Cream Support Group6 Reviews for Mycostatin Vaginal - Add your own review/rating Compare Mycostatin Vaginal Cream with other medications Cutaneous CandidiasisVaginal Yeast Infection
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