Urea 39% Cream

Generic Name: urea 39% cream

Over-the-Counter (OTC)

Brand Names:

Urea 39% Cream

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

Overview

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

Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.

Side Effects

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

Warnings

KEEP OUT OF REACH OF CHILDREN. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the 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.

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.

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.

Can I take Urea 39% Cream during 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.

What are the important warnings for Urea 39% Cream?

KEEP OUT OF REACH OF CHILDREN. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.