{"adverse_reactions":["ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication."],"clinical_pharmacology":["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."],"contraindications":["CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients."],"description":["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: urea chemical formula","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 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802"],"dosage_and_administration":["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 to properly use 50% Urea Emulsion 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. For skin: 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)."],"effective_time":"20230919","how_supplied":["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."],"id":"388706e1-e5e6-4038-9e23-f44b9ea94116","indications_and_usage":["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."],"keep_out_of_reach_of_children":["KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"nursing_mothers":["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"],"openfda":{},"package_label_principal_display_panel":["NDC 42192-101-10 50% Urea Emulsion In a zinc undecylenate and lactic acid vehicle Rx Only Net Weight 10 oz For Topical Use Only Indications: For use on rough dry skin conditions. See carton or package insert for instructions. USE ONLY AS DIRECTED BY A PHYSICIAN. Ingredients: Each gram of 50% Urea Emulsion contains 50% urea in a formulation consisting of caprylic or 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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Storage: Store at controlled room temperature 15 - 30C (59 - 86F) Protect from freezing. For lot number and expiration date, see crimp of tube. 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. Please see insert for further details. Manufactured for: Acella Pharmaceuticals 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802","urea label"],"pharmacokinetics":["PHARMACOKINETICS: The mechanism of action of the topically applied Urea is not yet known."],"precautions":["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: 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."],"set_id":"eea99462-75d3-423d-9e46-86434b9866d1","spl_product_data_elements":["UREA UREA TRICAPRIN CETYL ALCOHOL EDETATE DISODIUM GLYCERIN POWDERED CELLULOSE LACTIC ACID LINOLEIC ACID POLYETHYLENE GLYCOL 300 POLYSORBATE 60 PROPYLENE GLYCOL SORBITAN MONOSTEARATE TITANIUM DIOXIDE TROLAMINE WATER ALPHA-TOCOPHEROL XANTHAN GUM ZINC UNDECYLENATE UREA UREA"],"version":"5","warnings":["WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes."]}