INDICATIONS & USAGE SECTION.

INDICATIONS USAGE 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 eshar. 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.

Urea 41% Cream(TM). Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label.

PHARMACOKINETICS SECTION.

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

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 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:. Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

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 intracellular matrix which results in loosening of the horny layer of the skin and shedding of 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. Urea 41% is keratolytic emollient which is gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 410 mg of urea in vehicle consisting of: Aqua (Purified Water), Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Methylparaben, Paraffin, Propylene Glycol, Stearyl Alcohol, Xanthan Gum.Urea is diamide of carbonic acid with the following chemical structure:. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Apply Urea 41% to affected skin twice per day, or as directed by your 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. Urea 41% Cream oz. (227 g): NDC 59088-489-16.

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.