Storage and handling
Store at room temperature 15°C-30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed.
Urea Cream 40%
- Manufacturer
- Prime Labs, LLC dba Quality CDMO
- Effective date
- 2022-04-18
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:03:26
Label at a glance#
ProductUrea Cream 40%
Active ingredientUREA
Label structure4 sections
Contacts and useful links#
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
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Urea Cream 40%
- GLYCERIN
- UREA
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- WHITE PETROLATUM
- WATER
- STEARYL ALCOHOL
- CETYL ALCOHOL
- MINERAL OIL
- GLYCERYL STEARATE SE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80587-111 | 80587-111-01, 80587-111-03, 80587-111-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| UREA | 8W8T17847W | ACTIB |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| WHITE PETROLATUM | B6E5W8RQJ4 | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| GLYCERYL STEARATE SE | FCZ5MH785I | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 23e63ee9-8f9d-62ff-e063-6394a90a6508 | dcf39e60-9d80-4346-e053-2a95a90a6e99 | 2024-10-07 | dcf39e60-9d80-4346-e053-2a95a90a6e99 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.