The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product Urea Cream 40 Percent (NDC 58657-489). 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 and usage, contraindications, warnings, precautions, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients:
Carbomer, Cetearyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, White Petrolatum.
Urea is a diamide of carbonic acid with the following chemical structure:
Structure (Structure)
Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding 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 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.
Known hypersensitivity to any of the listed ingredients.
For topical use only. Avoid contact with eyes, lips or mucous membranes.
This medication 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.
PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea 40% should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea 40% is administered to a nursing woman.
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at
1-877-250-3427; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Apply Urea 40% 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 40% Cream
1 oz. (28.35 g): NDC 58657-489-01
Urea 40% Cream
3 oz. (85 g): NDC 58657-489-03
Urea 40% Cream
7 oz. (198.4 g): NDC 58657-489-07
Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
Method Pharmaceuticals, LLC
Southlake, Texas 76092
Rev. 09/23
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