Uracin 10% - PureTek Corporation

Uracin ^TM 10% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 100 mg of urea in a vehicle consisting of the following inactive ingredients : Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Butyrospermum Parkii (Shea) Butter, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isohexadecane, PEG-100 Stearate, Phenoxyethanol, Polysorbate 80, Purified Water, Sorbitan Oleate, Xanthan Gum.

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

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 eschar. 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.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Avoid contact with eyes, lips and mucous membranes.

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

To report SUSPECTED ADVERSE REACTIONS, contact PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

Apply Uracin™ 10% cream to affected area(s) twice daily, or as directed by your licensed healthcare practitioner. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice daily, or as directed by a licensed healthcare practitioner.

Uracin™ 10% cream is supplied in white plastic jars containing 8 oz (227 g) of cream, NDC 59088-256-16.

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.

Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 1-877-921-7873

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