{"adverse_reactions":["ADVERSE REACTIONS Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin. PHARMACOKINETICS The exact mechanism of action of topically applied urea is not known."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients"],"description":["DESCRIPTION Aluvea™ (urea) cream, 39% is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin. Each gram of Aluvea Cream contains 39% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax NF, glycerin 99.7% USP, isopropyl myristate, purified water, sorbitol 70% Solution USP, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate. CHEMICAL STRUCTURE Urea is diamide of Carbonic acid with the following structure: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATIONS Apply Aluvea to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed."],"effective_time":"20180411","how_supplied":["HOW SUPPLIED Aluvea is supplied in an 8oz. bottle. NDC 0259-1139-80 Store at room temperature 15°C -30°C (59°F-86°F). Protect from freezing."],"id":"d4700a9e-0e49-4c73-b85b-f705108f9c1f","indications_and_usage":["INDICATION AND USAGE Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses."],"mechanism_of_action":["Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin."],"nursing_mothers":["Nursing Mothers It is not known whether Aluvea is excreted in human milk, therefore caution should be exercised when administering to a nursing mother."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 227g Carton NDC 0259-1139-80 ALUVEA ™ 39% Urea Cream WITH UNIQUE CSP ™ VEHICLE TECHNOLOGY FOR EXTERNAL USE ONLY 8 oz. (227g) Rx ONLY Principal Display Panel - 227g Carton"],"pharmacokinetics":["PHARMACOKINETICS The exact mechanism of action of topically applied urea is not known."],"precautions":["PRECAUTIONS Urea should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use. Pregnancy Category C Animal reproduction studies have not been conducted with Aluvea. It is also not known whether Aluvea can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Aluvea should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether Aluvea is excreted in human milk, therefore caution should be exercised when administering to a nursing mother."],"pregnancy":["Pregnancy Category C Animal reproduction studies have not been conducted with Aluvea. It is also not known whether Aluvea can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Aluvea should be given to a pregnant woman only if clearly needed."],"set_id":"e878410d-6c1c-4580-a9f4-4d6df2c93de3","spl_product_data_elements":["Aluvea Urea Urea Urea Dimethyl isosorbide Glycerin Isopropyl Myristate Sorbitol Tridecyl Stearate Neopentyl Glycol Dicaprate Tridecyl Trimellitate"],"spl_unclassified_section":["(39% Urea Cream) RX ONLY","KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN","Manufactured for: Merz Pharmaceuticals, LLC Greensboro, NC 27410 5011457 12/10"],"storage_and_handling":["Store at room temperature 15°C -30°C (59°F-86°F). Protect from freezing."],"teratogenic_effects":["Category C Animal reproduction studies have not been conducted with Aluvea. It is also not known whether Aluvea can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Aluvea should be given to a pregnant woman only if clearly needed."],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}