UREA CREAM 40% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)

Available from:

Prime Labs, LLC dba Quality CDMO

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

unapproved drug other

Summary of Product characteristics

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
Prime Labs, LLC dba Quality CDMO
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
1