Urea and Salicylic Acid Cream Description

Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid.

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

Urea and Salicylic Acid Cream - Clinical Pharmacology

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.

Indications and Usage for Urea and Salicylic Acid Cream

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 dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

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

Warnings

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

Avoid contact with eyes, lips and mucous membranes.When using this product skin irritation and dryness is more likely to occur.

Adverse Reactions/Side Effects

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

Urea and Salicylic Acid Cream Dosage and Administration

Apply Urea 39.5% Cream with 2% Salicylic Acid 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.

How is Urea and Salicylic Acid Cream supplied

Urea 39.5% Cream with 2% Salicylic Acid 8 oz. (227 g): NDC 59088-210-16

STORAGE

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.

Urea 39.5% Cream™ with 2% Salicylic Acid

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