Urea 50 Gel

Name: Urea 50 Gel

Clinical pharmacology

Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin while shedding scaly skin at regular intervals, which then softens the 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.

Packaging

Urea 50 Applicator labeling:

Urea 50 Applicator carton:

UREA 50 
urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-404
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 500 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49769-404-12 12 mL in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/06/2010
Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 01/2010   Kylemore Pharmaceuticals, LLC
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