URE-K Description

URE-K 50% cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.

Each gram of URE-K 50% cream contains:

ACTIVE: 50% Urea in a cream base of:

INACTIVES: Mineral Oil, Stearic Acid, Water, Glycerin, Polysorbate 20, Sepigel 305, Phenoxyethanol, Acrylate Copolymer and Vitamin E

URE-K - 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.

Indications and Usage for URE-K

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

URE-K 50% cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients.

Warnings

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

Precautions

After applying this medication, wash hands and unaffected areas thoroughly. Stop use and ask a doctor if redness or irritation develops. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Adverse Reactions/Side Effects

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

URE-K Dosage and Administration

Apply URE-K 50% cream 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 is URE-K supplied

URE-K 50% cream (50% urea) is supplied in:

Manufactured for:
Solutech Pharmaceuticals LLC
Peoria, AZ 85345

Rx only

PRINCIPAL DISPLAY PANEL - 142 gm Tube Label

NDC 70350-2600-5

FOR TOPICAL USE ONLY

URE-K 50%

50% UREA IN A CREAM BASE

Smooth
Easily Spreadable

Rx only

Solutech
PHARMACEUTICALS

Net WT. 5OZ (142 gm)