Label: UREA cream
- NDC Code(s): 42792-101-08
- Packager: AUSTIN PHARMACEUTICALS, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated December 11, 2018
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- SPL UNCLASSIFIED SECTION
This product is a keratolytic, emollient which is a gentle, yet potent, tissue softener for skin.
Each gram contains 390 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, sodium hydroxide, water, and xanthan gum.
Urea is a diamide of carbonic acid with the following chemical structure:
- CLINICAL PHARMACOLOGY:
- ADVERSE REACTIONS:
- DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42792-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 390 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42792-101-08 227 g in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/09/2011 Labeler - AUSTIN PHARMACEUTICALS, LLC (078398514)