UREA by AUSTIN PHARMACEUTICALS, LLC / Medical Products Laboratories, Inc. UREA cream

UREA by

Drug Labeling and Warnings

UREA by is a Prescription medication manufactured, distributed, or labeled by AUSTIN PHARMACEUTICALS, LLC, Medical Products Laboratories, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

INDICATIONS:

CONTRAINDICATIONS:

WARNING:

KEEP OUT OF REACH OF CHILDREN.

PRECAUTIONS:

ADVERSE REACTIONS:

DOSAGE AND ADMINISTRATION:

STORAGE:

HOW SUPPLIED:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UREA 
urea cream

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)