Urea 40% drug information

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

CONTRAINDICATIONS This product is contraindicated in people with known or suspected hypersensitivity to any of the ingredients of the product.

WARNING KEEP OUT OF REACH OF CHILDREN.

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

Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. To report SUSPECTED ADVERSE REACTIONS, contact Patrin Pharma at 1-800-936-3088 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch for voluntary reporting of suspected adverse reactions. Made in the USA Manufactured for: Patrin Pharma Skokie, IL 60076 Questions (800) 936 3088 Rev 01.0525

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

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.

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

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. Information for Patients 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. 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.

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.

Information for Patients 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. 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.

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

HOW SUPPLIED 28.35 g (1 oz.) bottles, NDC 39328-019-01 85 g (3 oz.) bottles, NDC 39328-019-03 198.4 g (7 oz.) bottles, NDC 39328-019-07