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Urea Cloths

Pronunciation

Dosage Form: topical cloth

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Urea 42% Cloths

DESCRIPTION:

Urea 42% Cloths contain a 42% solution of urea on a textured cloth. Each gram of medicated solution contains Purified Water, Urea, Glycerine, Polyacrylate, Caprylic/Caric TriGlyceride, Propylene Gycol, Xanthan Gum, Disodium EDTA, Zinc Pyrithione, Vitamin E Acetate, Lactic Acid, Citric Acid and Sodium Citrate.

CLINICAL PHARMACOLOGY:

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

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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, icthyosis, eczema, keratosis pilaris, kertosis palmaris, kertoderma, cons 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, Urea 42% Cloths 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 Urea 42% Cloths are 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:

Gently apply Urea 42% Cloths to affected skin twice per day, or as directed by a physician.

HOW SUPPLIED:

Urea 42% Cloths, NDC 68032-222-75, are supplied in a carton containing 30 foil pouches, each with a single-use medicated cloth ( 12 mL each).

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

Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024

Rev. 08/08 222-11

PRODUCT PACKAGING:

UREA 
urea cloth
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-222
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea (Urea) Urea 420 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
MEDIUM-CHAIN TRIGLYCERIDES  
PROPYLENE GLYCOL  
XANTHAN GUM  
EDETATE DISODIUM  
PYRITHIONE ZINC  
ALPHA-TOCOPHEROL ACETATE  
LACTIC ACID  
CITRIC ACID MONOHYDRATE  
SODIUM CITRATE  
Packaging
# Item Code Package Description
1 NDC:68032-222-75 12 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/06/2008 11/30/2011
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010
 
River's Edge Pharmaceuticals, LLC



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