Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied Urea 41% Cream 8 oz.(227 g): NDC 16477-341-08 Store at room temperature 15°C - 30°C (59°F - 86°F). Protect from freezing. Keep bottle tightly closed.; NDC 16477-341 Rx Only For topical use only Not for ophthalmic use Urea Cream 41% LASER PHARMACEUTICALS, LLC label
- How Supplied Urea 41% Cream 8 oz.(227 g): NDC 16477-341-08 Store at room temperature 15°C - 30°C (59°F - 86°F). Protect from freezing. Keep bottle tightly closed.
- NDC 16477-341 Rx Only For topical use only Not for ophthalmic use Urea Cream 41% LASER PHARMACEUTICALS, LLC label
Overview
Urea 41% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 41% contains 41% urea as an active ingredient, and the following inactive ingredients: Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure: image description
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 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 & Administration
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. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.
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 medication.
Keep Out of Reach of Children
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.