Label: UREA 41%- urea cream

Urea 41% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 410 mg of urea in a vehicle consisting of: Aqua (Purified Water), Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Methylparaben, Paraffin, Propylene Glycol, Stearyl Alcohol, Xanthan Gum.

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

Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

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 eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.

Avoid contact with eyes, lips and mucous membranes.

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

Apply Urea 41% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.

Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

Urea 41% Cream 8 oz. (227 g): NDC 59088-489-16

Store at 20° to 25°C (68° to 77°F) [see USP Controlled
Room Temperature]. Protect from freezing and excessive
heat. Keep container tightly closed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873