Urea Cream 40% by Prime Labs, LLC dba Quality CDMO Urea Cream 40%

Urea Cream 40% by

Drug Labeling and Warnings

Urea Cream 40% by is a Prescription medication manufactured, distributed, or labeled by Prime Labs, LLC dba Quality CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UREA CREAM 40%- urea cream 40% cream 
Prime Labs, LLC dba Quality CDMO

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Urea Cream 40%

INGREDIENTS: Each gram
of Urea Cream 40%
contains Urea 40% and the
following inactive
ingredients: Carbomer,
Cetearyl Alcohol, Glycerin,
Glyceryl Stearate SE,
Mineral Oil, Purified Water,
White Petrolatum.

Store at room
temperature 15°C-30°C
(59°F-86°F).
Protect from freezing.
Keep bottle tightly closed.

This product is supplied in the following size(s): 3 oz, 1 oz, and 7oz

To report a serious adverse event or obtain product information, call 877-250-3427

To report a serious adverse event, please contact Method Pharmaceuticals at (877) 250-3427; email at contact@methodpharm.com; or call FDA at (800) FDA-1088.

Manufactured for:

Method Pharmaceuticals, LLC Fort Worth, Texas 76118

Rev. 11/21

7 oz label3 oz label1 oz label

UREA CREAM 40% 
urea cream 40% cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 80587-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA400 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80587-111-0128 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
2NDC: 80587-111-0385 g in 1 BOTTLE; Type 0: Not a Combination Product11/18/2021
3NDC: 80587-111-07198.4 g in 1 BOTTLE; Type 0: Not a Combination Product11/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/18/202109/27/2024
Labeler - Prime Labs, LLC dba Quality CDMO (117658386)

Revised: 10/2024