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----------50% UREA EMULSION
DESCRIPTION: Each gram of 50% Urea Emulsion contains 50% urea in a formulation consisting of: caprylic/capric triglyceride, cetyl alcohol, disodium EDTA, glycerin, hydroxyethyl cellulose, lactic acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, sorbitan stearate, titanium dioxide, triethanolamine, purified water, vitamin E, xanthan gum and zinc undecylenate.
Urea is a diamide of carbonic acid with the following chemical structure:
CLINICAL PHARMACOLOGY: 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.
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.
PRECAUTIONS: 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.
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 reproduction studies are not always predictive of human response, 50% Urea Emulsion 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 50% Urea Emulsion is administered to a nursing woman
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
DOSAGE AND ADMINISTRATION: Apply 50% Urea Emulsion to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.
HOW SUPPLIED: 50% Urea Emulsion is supplied in a 10 oz. tube (NDC 42192-101-10). Store at controlled room temperature, 15° - 30° (59° - 86°F). Protect from freezing.
All prescription substitutions 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. 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, incipients, inactive ingredients and chemical formulation information provided herein.
MANUFACTURED FOR: Acella Pharmaceuticals, LLC
How to properly use
In a zinc undecylenate and lactic acid vehicle
Easy steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris,
keratoderma, dermatitis, pruritus, eczema, corns and calluses.
1. Apply 50% Urea Emulsion to affected skin twice per day, or as directed by a physician.
2. Rub in until completely absorbed (for best results apply to moistened skin).
Indications: For use on rough dry skin
USE ONLY AS DIRECTED BY A
Ingredients: Each gram of 50% Urea
KEEP THIS AND ALL MEDICATIONS OUT
Storage: Store at controlled room temperature
For lot number and expiration date, see
All prescription substitutions using this
Revised: 12/2010 ACELLA PHARMACEUTICALS
Reproduced with permission of U.S. National Library of Medicine
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