Dosage and administration
Apply Urea 41% 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 41% Cream
- Manufacturer
- Oncora Pharma, LLC
- Effective date
- 2025-06-11
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 21:35:12
Label at a glance#
ProductUrea 41%
Active ingredientUREA
Label structure8 sections
Label contents#
Full prescribing information#
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
Avoid contact with eyes, lips and mucous membranes.
ADVERSE REACTIONS:
Discontinue use and consult a physician if redness or irritation occurs.
DOSAGE AND ADMINISTRATION
Apply Urea 41% 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 41% Cream 8 oz. (227 g): NDC 85477-905-30
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 41% Cream™
Oncora Pharma
Dallas, TX 75161
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85477-905-30 | Urea 41% | 227 g in 1 BOTTLE | CREAM | 227 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 85477-905-30 | GM - Gram | 85477-905 | 526996be-0f77-4992-a646-20e810e553d5 | 1 | 2025-07-08 |
Products#
Every source-derived product name is available through these pages.
- Urea 41%
- Urea
- CETEARETH-20
- CETYL ALCOHOL
- PARAFFIN
- PROPYLENE GLYCOL
- WATER
- C13-14 ISOPARAFFIN
- XANTHAN GUM
- POLYACRYLAMIDE (10000 MW)
- PHENOXYETHANOL
- LAURETH-7
- ETHYLHEXYLGLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85477-905 | 85477-905-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETEARETH-20 | YRC528SWUY | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| C13-14 ISOPARAFFIN | E4F12ROE70 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| UREA | 8W8T17847W | ACTIB |
| POLYACRYLAMIDE (10000 MW) | E2KR9C9V2I | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| LAURETH-7 | Z95S6G8201 | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | 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 |
|---|---|---|---|---|---|---|
| Urea 41% | UREA | Oncora Pharma, LLC | 37576876-738c-ac79-e063-6394a90a84fe | 2025-06-11 | Warnings, Adverse reactions | 85477-905-30 85477-905 85477090530 37576876-738d-ac79-e063-6394a90a84fe 37576876-738c-ac79-e063-6394a90a84fe |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.