Dosage and administration
Apply Urea 39.5% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
Urea 39.5% Cream Rx Only
- Manufacturer
- PureTek Corporation
- Effective date
- 2023-01-20
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:46:32
Label at a glance#
ProductUrea 39.5%
Active ingredientUREA
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION
Urea 39.5% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 395 mg of urea in a vehicle consisting of: Aqua (Purified Water), Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Methylparaben, Paraffin, Propylene Glycol, Stearyl Alcohol, Xanthan Gum.
Urea is a diamide of carbonic acid with the following chemical structure:
CLINICAL PHARMACOLOGY
Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of 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 & USAGE
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.
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 medication.
DOSAGE AND ADMINISTRATION
Apply Urea 39.5% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
HOW SUPPLIED
Urea 39.5% Cream 8 oz. (227 g): NDC 59088-698-16
STORAGE
Store at 20° to 25°C (68° to 77°F) [see USP Controlled
Room Temperature]. Protect from freezing and excessive
heat. Keep container tightly closed.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Urea 39.5% Cream™
Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free:
877-921-7873
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59088-698-16 | Urea 39.5% | 227 g in 1 JAR | CREAM | 227 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59088-698-16 | GM - Gram | 59088-698 | 060b3f7b-b235-4bca-9cb2-9f0fd3a53647 | 1 | 2023-02-06 |
Products#
Every source-derived product name is available through these pages.
- Urea 39.5%
- Urea
- CETEARETH-25
- CETEARETH-6
- CETYL ALCOHOL
- METHYLPARABEN
- PARAFFIN
- PROPYLENE GLYCOL
- WATER
- STEARYL ALCOHOL
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59088-698 | 59088-698-16 |
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 |
|---|---|---|---|---|---|---|
| Urea 39.5% | UREA | PureTek Corporation | ea2adf3e-cea6-43b2-e053-2995a90a89a6 | 2023-01-20 | Warnings, Adverse reactions | 59088-698-16 59088-698 59088069816 ea2adf3e-cea5-43b2-e053-2995a90a89a6 ea2adf3e-cea6-43b2-e053-2995a90a89a6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.