Home – UREA

UREA

Urea Cream 39%

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION:

UREA

FOR EXTERNAL USE ONLY.

General:

Pregnancy: Pregnancy Category C.

Nursing Mothers:

You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

KEEP OUT OF REACH OF CHILDREN.

Austin Pharmaceuticals, LLC

UREA

UREA CREAM

Product Information
Product Type	Human prescription drug label	Item Code (Source)	NDC:42792-101
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA		390 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
DIMETHYL ISOSORBIDE
GLYCERYL MONOSTEARATE
Mineral Oil
petrolatum
propylene glycol
SODIUM HYDROXIDE
water
XANTHAN GUM

Product Characteristics
Color
white

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC:42792-101-08	227 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
		2011-03-09

PLEASE, BE CAREFUL!

Be sure to consult your doctor before taking any medication!