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.

DESCRIPTION SECTION.

DESCRIPTION:. Each gram contains 410 mg of urea in vehicle consisting of: ceteareth-25, ceteareth-6, cetyl alcohol, methylparaben, paraffin, propylene glycol, propylparaben, purified water, stearyl alcohol, xanthan gum.Urea is diamide of carbonic acid with the following 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.See package insert 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.

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.

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 20C to 25C (68F to 77F), excursions permitted between 15C to 30C (between 59F to 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimized.

SPL UNCLASSIFIED SECTION.

NDC 58657-486-08Urea 41% CreamFor External Use Only Rx OnlyNet Wt. oz. (227 gUrea 41%CreamMethod Pharmaceuticals, LLCDisclaimer:ThisdrughasnotbeenfoundbyFDAtobesafe andeffective,andthislabelinghasnotbeenapprovedbyFDA.----------Urea 41%Cream.

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.