Dosage and administration
Use as directed by your physician. See label booklet for full Prescribing Information.
Urea 40 Percent Cream
- Manufacturer
- Bryant Ranch Prepack
- Effective date
- 2026-04-24
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 103
- Source
- full-release
- Hydrated at
- 2026-05-31 22:16:29
Label at a glance#
ProductUrea 40 Percent
Active ingredientUREA
Label structure10 sections
Label contents#
Full prescribing information#
DESCRIPTION:
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.
CLINICAL PHARMACOLOGY:
Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.
Pharmacokinetics:
The mechanism of action of topically applied urea is not yet known.
INDICATIONS:
This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
CONTRAINDICATIONS:
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
WARNINGS:
FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.
Avoid contact with eyes, lips and mucous membranes.
General:
This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.
Information for Patients:
Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.
Pregnancy:
Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
ADVERSE REACTIONS:
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
DOSAGE AND ADMINISTRATION:
Use as
directed by your physician.
See label booklet for full
Prescribing Information.
STORAGE:
Store at room
temperature 15°C-30°C
(59°F-86°F).
Protect from freezing.
Keep bottle tightly closed.
HOW SUPPLIED:
Urea 40% Cream
- This product is supplied in the following size: 7oz NDC 63629-9267-1
Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Urea 40% Cream
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  dailymed.nlm.nih.gov/dailymed/search.cfm?query=63629-9267-1 | lbl636299267.jpg | |
| Data code | Code 128 | 6362992671 | lbl636299267.jpg | |
| Data code | Data Matrix | 0100363629103317211444981724013110LOT42832 | lbl636299267.jpg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-9267-1 | Urea 40 Percent | 198.4 g in 1 BOTTLE | CREAM | 198.4 | 103 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-9267-1 | GM - Gram | 63629-9267 | d0479f43-1538-4d17-9058-c15560f7f1d1 | 1 | 2022-06-06 |
| 58657-487-01 | GM - Gram | 58657-487 | 6cc9ad67-4027-4a1a-977f-6cf12e226394 | 1 | 2022-02-07 |
| 58657-487-03 | GM - Gram | 58657-487 | e3820119-276c-4c8a-8c62-164a4b76514a | 1 | 2022-02-07 |
| 58657-487-07 | GM - Gram | 58657-487 | b02e37c2-ec4f-48de-b296-a5fc2cf8097d | 1 | 2022-02-07 |
Products#
Every source-derived product name is available through these pages.
- Urea 40 Percent
- Urea
- GLYCERIN
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- CETYL ALCOHOL
- WHITE PETROLATUM
- MINERAL OIL
- WATER
- GLYCERYL STEARATE SE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63629-9267 | 63629-9267-1 |
| 58657-487 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| WHITE PETROLATUM | B6E5W8RQJ4 | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERYL STEARATE SE | FCZ5MH785I | IACT |
| UREA | 8W8T17847W | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Urea 40 Percent | UREA | Bryant Ranch Prepack | 6701225c-2c2e-41e8-8d43-ef77c00a9946 | 2026-04-24 | Warnings, Adverse reactions | 63629-9267-1 63629-9267 63629926701 e91f44df-bbf1-484a-b84f-73ca9e47545e 6701225c-2c2e-41e8-8d43-ef77c00a9946 |
| Urea 40 Percent | UREA | Method Pharmaceuticals, LLC | d35b75e1-937d-ebc4-e053-2a95a90ac0d8 | 2026-02-12 | Warnings, Adverse reactions | 58657-487 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.