CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix, which results in loosening the hornylayer 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 removal of devitalized nail plate tissue.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

DESCRIPTION: UREA CREAM 45% is keratolytic emollient, which is gentle, yet potent, tissue softener for nails and/orskin. Each gram contains 45% Urea in cream base of: camphor, edetate disodium, alcohol, eucalyptus oil, hydroxyethyl cellulose, menthol, purified water, titanium dioxide, sodium hydroxide. CHEMISTRY: Urea is diamide of carbonic acid with the following chemical structure: structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINSTRATION: Apply Urea Cream 45% to damaged nail tissue or affected skin area(s) twice day oras directed by physician.

HOW SUPPLIED SECTION.

HOW SUPPLIED: Urea Cream 45% is supplied in oz. (255 g) tubes, NDC 42808-0202-09.

ADVERSE REACTIONS SECTION.

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

INDICATIONS & USAGE SECTION.

INDICATIONS AND USES: Urea 45% Cream is indicated for use in the topical treatment for debridement and promotionof 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 devitalized and ingrown nails.

NURSING MOTHERS SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. For External Use OnlyNDC 42808-0202-09 Rx OnlyUrea In vehicle containing camphor, eucalyptus oil and menthol 45%CREAMExact-Rx. INCORPORATED Net Wt. oz (255 g). Carton.

PHARMACOKINETICS SECTION.

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

PRECAUTIONS SECTION.

PRECAUTIONS: Use this medication only as directed by physician. It should not be used to treat and condition otherthan that for which it was prescribed. 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 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 Cream 45%should be given to pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

(in cream base)Rx onlyFor external use only. Not for ophthalmic use. Keep away from eyes, lips and mucous membranes.

STORAGE AND HANDLING SECTION.

Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F). See USP Controlled Room Temperature. Protect from freezing.

WARNINGS SECTION.

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes. If swallowed seek medical attention or contact Poison Control Centter immediately.