Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied 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.; PRINCIPAL DISPLAY PANEL UREA CREAM 40% NDC 58657-489-01 28.35g UREA CREAM 40% NDC 58657-489-03 85g UREA CREAM 40% NDC 58657-489-07 198.4g tube 1 carton1 tube 2 carton2 1 3
- How Supplied 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.
- PRINCIPAL DISPLAY PANEL UREA CREAM 40% NDC 58657-489-01 28.35g UREA CREAM 40% NDC 58657-489-03 85g UREA CREAM 40% NDC 58657-489-07 198.4g tube 1 carton1 tube 2 carton2 1 3
Overview
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
Indications & Usage
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.
Dosage & Administration
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.
Warnings & Precautions
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.
Contraindications
Known hypersensitivity to any of the listed ingredients.
Adverse Reactions
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 .
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