Urea cloth

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.

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

Ingredients and appearance - Product information

Urea cloth- Urea

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68032-222
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Urea ( UNII: 8W8T17847W)( Urea - UNII: 8W8T17847W ) 420 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Glycerin ( UNII: PDC6A3C0OX)
Medium-chain triglycerides ( UNII: C9H2L21V7U)
Propylene glycol ( UNII: 6DC9Q167V3)
Xanthan gum ( UNII: TTV12P4NEE)
Edetate disodium ( UNII: 7FLD91C86K)
Pyrithione zinc ( UNII: R953O2RHZ5)
Alpha-tocopherol acetate ( UNII: 9E8X80D2L0)
Lactic acid ( UNII: 33X04XA5AT)
Citric acid monohydrate ( UNII: 2968PHW8QP)
Sodium citrate ( UNII: 1Q73Q2JULR)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - River's Edge Pharmaceuticals, LLC( 133879135)

Product packaging: