RE Urea 50 Emulsion

Name: RE Urea 50 Emulsion

Indications and uses

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 hyper-keratotic conditions such as dry, rough skin, dermatitis, psoriasis, ichthyosis, keratoderma, eczema, keratosis pilaris, keratosis palmaris, xerosis, corns and calluses, as well as damaged, devitalized, and ingrown nails.

Contraindications

Known hypersensitivity to any of the listed ingredients.

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 RE Urea 50 Emulsion is administered to nursing women.

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

Dosage and administration

Apply RE Urea 50 Emulsion to diseased or damaged nail and/or skin tissue twice per day, or as directed by a physician. (Apply to moistened skin for best results.)

RE Urea 50 Emulsion, NDC # 68032-403-13, is supplied in a 10 oz (283.5 g) tube.

Storage

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

Packaging

RE UREA 
urea emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-403
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
CETYL ALCOHOL  
EDETATE DISODIUM  
GLYCERIN  
LACTIC ACID  
LINOLEIC ACID  
MINERAL OIL  
POLYETHYLENE GLYCOL 300  
POLYSORBATE 60  
WATER  
STEARIC ACID  
TITANIUM DIOXIDE  
ZINC UNDECYLENATE  
Packaging
# Item Code Package Description
1 NDC:68032-403-13 283.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/30/2009 10/31/2011
Labeler - River's Edge Pharmaceuticals (133879135)
Revised: 12/2010   River's Edge Pharmaceuticals
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