ADVERSE REACTIONS SECTION.

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

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:. Each gram contains 470 mg of urea in vehicle consisting of: camphor, disodium EDTA, eucalyptus oil, hydroxyethyl cellulose, menthol, purified water, SD alcohol 40B 200 proof, and titanium dioxide.Urea is diamide of carbonic acid with the following chemical structure:. 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. oz. (142 g) bottles, NDC 52187-549-05 To report serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: KMM Pharmaceuticals, LLC 1000 N. West Street Suite 1200, 1021 Wilmington, DE 19801 2100359 [00] Rev. 07/2021.

INDICATIONS & USAGE SECTION.

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

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 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.

SPL UNCLASSIFIED SECTION.

Rx OnlyFOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

STORAGE AND HANDLING 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. NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed.

WARNINGS SECTION.

WARNING: KEEP OUT OF THE REACH OF CHILDREN.