FDA.reportPublic FDA data

Urea Cream 40%

Manufacturer
Prime Labs, LLC dba Quality CDMO
Effective date
2022-05-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:02:09

Label at a glance#

ProductUrea Cream 40%
Active ingredientUREA
Label structure4 sections

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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.

STORAGE AND HANDLING SECTION

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

HOW SUPPLIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 oz carton1 oz carton3 oz carton3 oz carton7 oz carton7 oz carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80587-11380587-113-01, 80587-113-03, 80587-113-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
MINERAL OILT5L8T28FGPIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
UREA8W8T17847WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
23e6326b-0542-6032-e063-6394a90ab0aade0a82b3-cd61-01d1-e053-2995a90a304b2024-10-07Exact identifier
spl set id: de0a82b3-cd61-01d1-e053-2995a90a304b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.