Data Source: Information sourced from the FDA OpenFDA database. Database last updated: March 2026. Learn more about our data sources →
Drug Pricing
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Uses & Indications
Indications and 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
Dosage and 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.
Side Effects
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 .
Warnings & Precautions
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.
Drug Interactions
No interactions listed. Consult your pharmacist.
Contraindications
Contraindications Known hypersensitivity to any of the listed ingredients.
Storage & Handling
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.