DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: Use as directed by your physician. See label booklet for full Prescribing Information.

GENERAL PRECAUTIONS SECTION.

General: This product is to be used as directed by 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 physician.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Urea 40% CreamThis product is supplied in the following size: 7oz NDC 63629-9267-1Repackaged/Relabeled by:Bryant Ranch PrepackBurbank, CA 91504. This product is supplied in the following size: 7oz NDC 63629-9267-1.

INDICATIONS & USAGE SECTION.

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.

INFORMATION FOR PATIENTS SECTION.

Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

NURSING MOTHERS SECTION.

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 nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Urea 40% Cream. Label.

PHARMACOKINETICS SECTION.

Pharmacokinetics: The mechanism of action of topically applied urea is not yet known.

ADVERSE REACTIONS SECTION.

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

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis and 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.

CLINICAL PHARMACOLOGY SECTION.

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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

DESCRIPTION SECTION.

DESCRIPTION:. INGREDIENTS: Each gram of Urea Cream 40% contains Urea 40% and the following inactive ingredients: Carbomer, Cetearyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, White Petrolatum.

PREGNANCY SECTION.

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 pregnant woman. This product should be used by pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

SAFE HANDLING WARNING SECTION.

STORAGE:. Store at room temperature 15C-30C (59F-86F). Protect from freezing. Keep bottle tightly closed.

WARNINGS SECTION.

WARNINGS: FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.Avoid contact with eyes, lips and mucous membranes.. General: This product is to be used as directed by 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 physician.. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if 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 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 pregnant woman. This product should be used by 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 nursing woman.