Urea

Exact-Rx, Inc.

Urea Cream 50% (in a cream base) Rx Only

FULL PRESCRIBING INFORMATION: CONTENTS*

• HOW SUPPLIED:
• PRINCIPAL DISPLAY PANEL-carton

FULL PRESCRIBING INFORMATION

DESCRIPTION: UREA CREAM 50% is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.

Each gram contains 50% Urea in a cream base of: Acrylates Copolymer, Carbopol, dl-Alphatocopheryl Acetate, Disodium EDTA, Glycerine, Lactic Acid, Mineral Oil, Polysorbate 85, Purified Water, Sodium Hydroxide, Stearic Acid and Zinc Pyrithione.

CHEMISTRY: Urea is a diamide of carbonic acid with the following chemical structure:

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.

PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known.

Uses

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 prurient 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, ingrown and devitalized nails.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

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

PRECAUTIONS: If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly KEEP THIS AND ALL MEDICATION 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 reproduction studies are not always predictive of human response, Urea Cream 50% should be given to a 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 Cream 50% is administered to a nursing woman.

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.

DOSAGE AND ADMINISTRATION: Apply Urea Cream 50% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.

HOW SUPPLIED:

Urea Cream, 50% is supplied in a 5 oz. (142 g) tube, NDC 42808-200-05, and a 9-oz. (255 g) tube NDC 42808-0200-09.

Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0200-99-205-00

Iss:5/11

PRINCIPAL DISPLAY PANEL-carton

For External Use Only

NDC 42808-0200-05        Rx Only

Urea
(50% Urea in a Cream Base)

50%

CREAM

Exact-Rx.
INCORPORATED

Net Wt. 5 oz (142 g)