Urea 39% Cream
Cream · Topical
Dosage and administration
Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.
Contraindications
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Warnings
KEEP OUT OF REACH OF CHILDREN.
Precautions
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Side effects
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
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.
Description
This product is a keratolytic emollient which is a gentle, yet potent, tissue softener for skin. Each gram contains 390 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, sodium hydroxide, water, and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: Structure
How supplied
8 oz. (227 g) bottles, NDC 44523-801-08
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.
Patient information
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.
Label text from the FDA structured product label by BioComp Pharma, Inc. (revised Jan 13, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Urea in 1 product
Urea 39% Cream NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 44523-801 | Urea 390 mg/g Cream | BioComp Pharma, Inc. | UNAPPROVED DRUG OTHER |
Frequently asked questions
What are the side effects of Urea 39% Cream?
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. See the full label for the complete list.
Who makes Urea 39% Cream?
Urea 39% Cream is listed by 1 labeler in the FDA NDC directory, including BioComp Pharma, Inc..