Prescription Drugs

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.

Utopic™ Cream (urea 41%) FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION Each gram contains 410 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, sodium hydroxide, water and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure:

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. DOSAGE AND ADMINISTRATION Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed. HOW SUPPLIED This product is supplied in the following size(s): 8 oz. (227 g) bottles, NDC 57893-301-08 10 g physician's sample, NDC 57893-301-10 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Artesa Labs, LLC 137585 Research Blvd. Suite 125 Austin, TX 78750 v1 Revised: Jul 2013

PATIENT INFORMATION Patients should discontinue the use of this product if the condition becomes worse or if a 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 a pregnant woman. This product should be used by a 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 a nursing woman.

OVERDOSE No information provided. CONTRAINDICATIONS This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

SIDE EFFECTS Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. DRUG INTERACTIONS No information provided.

WARNINGS KEEP OUT OF REACH OF CHILDREN. PRECAUTIONS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General This product is to be used as directed by a 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 a physician.