Dosage and administration
Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
Urea 40% Topical Cream
- Manufacturer
- Patrin Pharma, Inc
- Effective date
- 2025-08-21
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 21:44:56
Label at a glance#
ProductUrea 40%
Active ingredientUrea
Label structure13 sections
Storage and handling
Store at 20–25°C (68–77ºF), excursions permitted to 15–30ºC (59–86ºF). Protect from freezing and excessive heat. Keep bottle tightly closed
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx Only
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Each gram contains 400 mg of urea in a vehicle of carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide, and xanthan gum.
Urea is a diamide of carbonic acid with the 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
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 eschar. 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 people with known or suspected hypersensitivity to any of the ingredients of the product.
WARNING
KEEP OUT OF REACH OF CHILDREN.
PRECAUTIONS
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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. 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 will 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.
Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
STORAGE
Store at 20–25°C (68–77ºF), excursions permitted to 15–30ºC (59–86ºF). Protect from freezing and excessive heat. Keep bottle tightly closed
HOW SUPPLIED
28.35 g (1 oz.) bottles, NDC 39328-019-01
85 g (3 oz.) bottles, NDC 39328-019-03
198.4 g (7 oz.) bottles, NDC 39328-019-07
SPL UNCLASSIFIED SECTION
To report SUSPECTED ADVERSE REACTIONS, contact Patrin Pharma at 1-800-936-3088 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch for voluntary reporting of suspected adverse reactions.
Made in the USA
Manufactured for:
Patrin Pharma
Skokie, IL 60076
Questions (800) 936 3088
Rev 01.0525
PRINCIPAL DISPLAY PANEL - 28.35 g Bottle Carton
NDC 39328-019-01
Urea 40%
Topical Cream
For External Use Only
Not for Ophthalmic Use
Rx Only
Net Wt.
28.35 g (1 oz.)
PATRIN
PHARMA
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 39328-019-01 | Urea 40% | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 39328-019-01 | Urea 40% | 28.35 g in 1 BOTTLE, PLASTIC | CREAM | 28.35 | 1 | |
| 39328-019-03 | Urea 40% | 85 g in 1 BOTTLE, PLASTIC | CREAM | 85 | 1 | |
| 39328-019-07 | Urea 40% | 198.4 g in 1 BOTTLE, PLASTIC | CREAM | 198.4 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 39328-019-01 | GM - Gram | 39328-019 | 8a1ed534-32af-43c5-9e3c-f053febb83f5 | 1 | 2025-09-12 |
| 39328-019-03 | GM - Gram | 39328-019 | b857813f-e831-4335-9f58-83087e001a0e | 1 | 2025-09-12 |
| 39328-019-07 | GM - Gram | 39328-019 | 95bfd026-627e-482b-b026-4f8116516d0e | 1 | 2025-09-12 |
Products#
Every source-derived product name is available through these pages.
- Urea 40%
- Urea
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- Cetyl alcohol
- Dimethyl isosorbide
- Glyceryl monostearate
- Mineral oil
- Petrolatum
- Propylene glycol
- Water
- Sodium Hydroxide
- Xanthan gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 39328-019 | 39328-019-01, 39328-019-03, 39328-019-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Urea | 8W8T17847W | ACTIB |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| Cetyl alcohol | 936JST6JCN | IACT |
| Dimethyl isosorbide | SA6A6V432S | IACT |
| Glyceryl monostearate | 230OU9XXE4 | IACT |
| Mineral oil | T5L8T28FGP | IACT |
| Petrolatum | 4T6H12BN9U | IACT |
| Propylene glycol | 6DC9Q167V3 | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
| Xanthan gum | TTV12P4NEE | 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 40% | UREA | Patrin Pharma, Inc | 53ccf801-c1c6-42c8-a511-da33c308076f | 2025-08-21 | Warnings, Adverse reactions | 39328-019-01 39328-019-03 39328-019-07 39328-019 39328001901 39328001903 39328001907 2a3a53e2-6a1d-4422-b058-c9799cb3fa79 53ccf801-c1c6-42c8-a511-da33c308076f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.