ADVERSE REACTIONS SECTION.

Adverse Reactions. Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafetyavkare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

CONTRAINDICATIONS SECTION.

Contraindications. Known hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

Rx OnlyFor external use only. Not for ophthalmic use.DescriptionUrea 40% is keratolytic emollient which is gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40%contains 40% urea as an active ingredient, and the following inactive ingredients:Carbomer, Cetearyl Alcohol, Glycerin,Glyceryl Stearate SE, Mineral Oil, Purified Water,White PetrolatumUrea is diamide of carbonic acid with the following chemical structure:. structure.

DOSAGE & ADMINISTRATION SECTION.

Dosage and Administration. Apply Urea 40% 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.

HOW SUPPLIED SECTION.

How Supplied. Urea 40% Cream1 oz. (28.35 g): NDC 42291-849-28Urea 40% Cream oz. (85 g): NDC 42291-849-85Urea 40% Cream oz. (198.4 g): NDC 42291-849-19 Store at room temperature 15C 30C (59F-86F). Protect from freezing. Keep bottle tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE Pulaski, TN 38478 AV Rev. 10/21 (P) Rev. 10/21.

INDICATIONS & USAGE SECTION.

Indications and 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 eschar. 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.

NURSING MOTHERS SECTION.

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea 40% is administered to nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Tube Label. 28.35. 85. 198.4.

PHARMACOKINETICS SECTION.

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

PRECAUTIONS SECTION.

Precautions. This medication is to be used as directed by physician and should not be used to treat any condition other than that for whichit was prescribed. If redness or irritation occurs, discontinue use and consult physician.

PREGNANCY SECTION.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea 40% should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.

Warnings. For topical use only. Avoid contact with eyes, lips or mucous membranes.