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.

Urea 40% Cream

1 oz. (28.35 g): NDC: 42291-849-28

Urea 40% Cream

3 oz. (85 g): NDC: 42291-849-85

Urea 40% Cream

7 oz. (198.4 g): NDC: 42291-849-19


Store at room temperature 15°C - 30°C (59°F-86°F).

Protect from freezing. Keep bottle tightly closed.



KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.



Manufactured for:
AvKARE
Pulaski, TN 38478

AV Rev. 10/21 (P) Rev. 10/21

UREA CREAM 40% 
urea cream 40% cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80587-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80587-113-01	28 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022
2	NDC: 80587-113-03	85 g in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2021
3	NDC: 80587-113-07	198.4 g in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/18/2021	09/27/2024

Labeler - Prime Labs, LLC dba Quality CDMO (117658386)

Revised: 10/2024

Document Id: 23e6326b-0542-6032-e063-6394a90ab0aa

34391-3

Set id: de0a82b3-cd61-01d1-e053-2995a90a304b

Version: 3

Effective Time: 20241007