Document

DailyMed Label: Urea 39.5%

Title
DailyMed Label: Urea 39.5%
Date
2023
Document type
DailyMed Prescription
Name
Urea 39.5%
Generic name
Urea
Manufacturer
PureTek Corporation
Product information
NDC: 59088-698
Product information
NDC: 59088-698
Description
Urea 39.5% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 395 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:
Indications
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.
Dosage
Apply Urea 39.5% 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.
Contraindications
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse reactions
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
How supplied
Urea 39.5% Cream 8 oz. (227 g): NDC 59088-698-16
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.
Package label
Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873

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Product
CEM-Urea