Dosage and administration
Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. See package insert for full prescribing information.
Urea 41 Percent Cream
- Manufacturer
- Method Pharmaceuticals, LLC
- Effective date
- 2021-12-30
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:19:57
Label at a glance#
ProductUrea 41 Percent
Active ingredientUREA
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
NDC 58657-486-08
Urea 41% Cream
For External Use Only Rx Only
Net Wt. 8 oz. (227 g
Urea 41% Cream
Method Pharmaceuticals, LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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Urea 41% Cream
DESCRIPTION:
Each gram contains 410 mg of urea in a vehicle consisting of: ceteareth-25, ceteareth-6, cetyl alcohol, methylparaben, paraffin, propylene glycol, propylparaben, purified water, stearyl alcohol, xanthan gum.
Urea is a diamide of carbonic acid with the following chemical structure:
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:
FOR EXTERNAL USE ONLY. NOT FOR 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:
Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.
See package insert for full prescribing information.
STORAGE:
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.
NOTICE:
Protect from freezing and excessive heat. Keep bottle tightly closed.
HOW SUPPLIED:
This product is supplied in the following size(s): 8 oz. (227 g) bottles, NDC # 58657-486-08
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. 04/18
PRINCIPAL DISPLAY PANEL
Urea 41 Cream
For External Use Only
Rx Only
Net Wt. 8 oz. (277 g)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58657-486-08 | 2020-02-11 | C162847 | 48780-1 | 9d75b9d0-7d7d-f424-e053-dadaa90a57ce | Urea 41 Percent Cream |
| 58657-486-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7d7d-f424-e053-dadaa90a57ce | Urea 41 Percent Cream |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-486-08 | GM - Gram | 58657-486 | dd620f45-b113-4b7a-be56-c7edf91eb115 | 1 | 2018-06-11 |
Products#
Every source-derived product name is available through these pages.
- Urea 41 Percent
- Urea
- CETEARETH-25
- CETEARETH-6
- CETYL ALCOHOL
- METHYLPARABEN
- PARAFFIN
- PROPYLENE GLYCOL
- WATER
- STEARYL ALCOHOL
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58657-486 | 58657-486-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETEARETH-25 | 8FA93U5T67 | IACT |
| CETEARETH-6 | 2RJS3559D3 | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| XANTHAN GUM | TTV12P4NEE | 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 |
|---|---|---|---|---|---|---|
| d45ef5a6-32d9-32a5-e053-2995a90af51a | 96a025b6-d189-4372-8930-f4372c4aba68 | 2021-12-30 | Warnings, Adverse reactions | d45ef5a6-32d9-32a5-e053-2995a90af51a 96a025b6-d189-4372-8930-f4372c4aba68 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.