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.

SPL UNCLASSIFIED SECTION.

Rx OnlyFOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

STORAGE AND HANDLING SECTION.

STORAGE. Store at 20-25C (68-77oF), excursions permitted to 15-30oC (59-86oF). Protect from freezing and excessive heat. Keep bottle tightly closed.

WARNINGS SECTION.

WARNING. KEEP OUT OF REACH OF CHILDREN.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Transient stinging, burning, itching or irritation may occur and will 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. 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 people with known or suspected hypersensitivity to any of the ingredients of the product.

DESCRIPTION SECTION.

DESCRIPTION. Each gram contains 400 mg of urea in vehicle of carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide, and xanthan gum.Urea is diamide of carbonic acid with the chemical structure:. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Apply to affected area(s) twice per day or as directed by physician. Rub in until completely absorbed.Apply to diseased or damaged nail(s) twice per day, or as directed by physician.

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. 28.35 (1 oz.) bottles, NDC 39328-019-0185 (3 oz.) bottles, NDC 39328-019-03198.4 (7 oz.) bottles, NDC 39328-019-07.

INDICATIONS & USAGE SECTION.

INDICATIONS. For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

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.

PRINCIPAL DISPLAY PANEL 28.35 Bottle Carton. NDC 39328-019-01Urea 40% Topical CreamFor External Use Only Not for Ophthalmic UseRx OnlyNet Wt. 28.35 (1 oz.)PATRIN PHARMA. Chemical Structure.

PHARMACOKINETICS SECTION.

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

PRECAUTIONS SECTION.

PRECAUTIONS. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.. 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. 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.