FDA Label for Urea 39% Cream

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.

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 - UREA

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:

This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

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.

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 & Impairment Of Fertility

Long-term animal studies for carcinogenic potential have not been performed on this product to date. 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 normally disappear upon discontinuing the use of this product.

Dosage & Administration

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

Storage And Handling

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.

Notice:

Protect from freezing and excessive heat. Keep bottle tightly closed.

How Supplied

8 oz. (227 g) bottles, NDC 44523-801-08

Other

To report a serious adverse event or obtain product information, call (866) 762-2365.

Manufactured for:
BIOCOMP PHARMA, INC.
San Antonio, TX 78230 1355

2100669 [00] R1021