Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied Urea Lotion 40% 8 oz. (226.8g): NDC 71399-8455-8 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. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. 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 such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein. QUESTIONS : Please Call 1(877) 225-6999 Manufactured for: Akron Pharma, Inc, Fairfield, NJ 07004 Manufactured in U.S.A; 40
- How Supplied Urea Lotion 40% 8 oz. (226.8g): NDC 71399-8455-8 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. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. 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 such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein. QUESTIONS : Please Call 1(877) 225-6999 Manufactured for: Akron Pharma, Inc, Fairfield, NJ 07004 Manufactured in U.S.A
- 40
Overview
Rx Only For external use only. Not for ophthalmic use. Description 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: Purified Water, Propylene Glycol, Glyceryl Monostearate, Mineral Oil, Cetyl Alcohol, Phosphomer X-Polymer, Trolamine 99% , White Petrolatum, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure: struct
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 medication.
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