The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Urea 41% (NDC 59088-489). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, pharmacokinetics, indications & usage, contraindications, warnings, general, information for patients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
The mechanism of action of topically applied urea is not yet known.
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.
This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.
Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.
Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.
Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
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
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call toll-free:
877-921-7873
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