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Urea Suspension

Pronunciation

Dosage Form: topical suspension

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.

50% Urea Topical Suspension

DESCRIPTION:

Each gram of 50% Urea Topical Suspension contains: Urea 50%, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Disodium EDTA, Glycerin, Hydroxyethylcellulose, Lactic Acid, Linoleic Acid, PEG-6, Polysorbate 60, Propylene Glycol, Water, Salicylic Acid, Sorbitan Stearate, Titanium Dioxide, Triethanolamine, Tocopheryl Acetate, Xanthan Gum.

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

     NH2
        |
     C=O
        |
     NH2

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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.

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 pilaris, keratosis palmaris, 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 reproduction studies are not always predictive of human response, 50% UREA TOPICAL SUSPENSION 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 50% Urea Topical Suspension 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 50% UREA TOPICAL SUSPENSION to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

HOW SUPPLIED:

50% UREA TOPICAL SUSPENSION is supplied as a 284 g (10 oz) tube, NDC 68032-261-13
Store at controlled room temperature 15°-30° C (59°-86° F).

Protect from freezing.

PACKAGING:

UREA 
Urea Suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-261
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
MEDIUM-CHAIN TRIGLYCERIDES  
CARBOMER 1342  
CETYL ALCOHOL  
EDETATE DISODIUM  
GLYCERIN  
HYPROMELLOSE 2208 (100 MPA.S)  
LACTIC ACID  
LINOLEIC ACID  
POLYETHYLENE GLYCOL 300  
POLYSORBATE 60  
PROPYLENE GLYCOL  
WATER  
SALICYLIC ACID  
SORBITAN MONOSTEARATE  
TITANIUM DIOXIDE  
TROLAMINE  
XANTHAN GUM  
Packaging
# Item Code Package Description
1 NDC:68032-261-13 284 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/17/2009 11/22/2011
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 11/2011
 
River's Edge Pharmaceuticals, LLC



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