ADVERSE REACTIONS SECTION.

Adverse Reactions. Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

CLINICAL PHARMACOLOGY SECTION.

URE-39 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. 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.

CONTRAINDICATIONS SECTION.

Contraindications. URE-39 Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

URE-39 Description. URE-39 Cream is potent keratolytic emollient which is gentle, yet potent, tissue softener for skin and/or nails.Each gram of URE-39 Cream contains:ACTIVE: 39% Urea in cream base of:INACTIVES: Deionized Water, Carthamus Tinctorius (Safflower) Seed Oil, Emulsifying Wax, Glycerine, Propylene Glycol, Glyceryl Stearate, PEG 100 Stearate, Cetyl Alcohol, Dimethicone, C12/15 Alkyl Benzoate, Anthemis Nobilis (Chamomile) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, and Isobutylparaben. CHEMISTRY. Urea is diamide of carbonic acid with the following chemical structure:. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

URE-39 Dosage and Administration. Apply URE-39 Cream to affected skin two to three times per day as needed or as directed by physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue two to three times per day or as directed by physician. Best applied to affected areas immediately after showering and just before bedtime.

HOW SUPPLIED SECTION.

How is URE-39 Supplied. URE-39 (39% Urea Cream) is supplied in:8oz (227gm) JarNDC: 70350-2612-1. Store at 25C (77F); excursions permitted to 15C 30C (59 86F). Protect from freezing. [See USP Controlled Room Temperature.].

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 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.

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 URE-39 Cream is administered to nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 227 gm Jar Label. NDC 70350-2612-1FOR TOPICAL USE ONLYURE-39UREA 39% CREAMSmooth Easily SpreadableRx onlySolutech PHARMACEUTICALS Net WT.8OZ (227 gm). PRINCIPAL DISPLAY PANEL 227 gm Jar Label.

PHARMACOKINETICS SECTION.

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

PRECAUTIONS SECTION.

Precautions. Stop use and ask doctor if redness or irritation develops. After applying this medication, wash hands and unaffected areas thoroughly. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.. 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 reproduction studies are not always predictive of human response, URE-39 Cream 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 URE-39 Cream is administered to nursing woman.

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 reproduction studies are not always predictive of human response, URE-39 Cream should be given to pregnant woman only if clearly needed.

STORAGE AND HANDLING SECTION.

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

WARNINGS SECTION.

Warnings. For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin.