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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Drug Label Information
Updated August 25, 2022
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- GENERAL:
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DESCRIPTION:
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:
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- INFORMATION FOR PATIENTS:
- CARCINOGENISIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY:
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PREGNANCY
Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
- NURSING MOTHERS:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UREA
urea creamProduct 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) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 manufacture(42792-101) , label(42792-101) , analysis(42792-101) , pack(42792-101)