Urea 39% Cream
FDA Drug Information • Also known as: Urea 39% Cream
- Brand Names
- Urea 39% Cream
- Route
- TOPICAL
- Dosage Form
- CREAM
- Product Type
- HUMAN PRESCRIPTION DRUG
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
Dosage and Administration
Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.
Side Effects (Adverse Reactions)
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Warnings and Precautions
KEEP OUT OF REACH OF CHILDREN.
Contraindications
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Pregnancy and Breastfeeding
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.
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.
How Supplied
8 oz. (227 g) bottles, NDC 44523-801-08
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.