PREGNANCY SECTION.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to 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 Nail Gel 45% should be given to pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

For external use only. Not for ophthalmic use. Keep away from eyes, lips and mucous membranes.

STORAGE AND HANDLING SECTION.

Store at controlled room temperature 15 to 30C (59 to 86F). Protect from freezing.Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 1174700-0204-28-205-00Iss:7/11.

WARNINGS SECTION.

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY: Urea gently dissolves the intracellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

DESCRIPTION: UREA Nail Gel 45% is keratolytic emollient, which is gentle, yet potent, tissue softener for nails and/or skin. Each gram of UREA Nail Gel 45% contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water. UREA is diamide of carbonic acid with the following chemical structure:. Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: Apply Urea Nail Gel 45% to diseased or damaged nail tissue twice per day, or as directed by physician.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Urea Nail Gel 45% is supplied in 28 mL glass bottle NDC 42808-0204-28.. Store at controlled room temperature 15 to 30C (59 to 86F). Protect from freezing.Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 1174700-0204-28-205-00Iss:7/11.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USES: 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, keratoderma, corns and calluses, as well as damaged and ingrown nails.

INSTRUCTIONS FOR USE SECTION.

DIRECTIONS FOR SKIN: Apply Urea Nail Gel 45% to affected area(s) twice per day, or as directed by physician. Rub in until gel is absorbed.

NURSING MOTHERS SECTION.

NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea Nail Gel 45% is administered to nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. For External Use OnlyNDC 42808-0204-28 Rx OnlyUrea In vehicle containing menthol, camphor eucalyptus oil 45%NAIL GELExact-Rx. INCORPORATED Net Wt. 28 mL. Carton.

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 which it was prescribed. If redness or irritation occurs, discontinue use. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. . PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to 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 Nail Gel 45% should be given to pregnant woman only if clearly needed. . NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea Nail Gel 45% is administered to nursing woman.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication. Call your doctor for medical advice about side effects.