{"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. PHARMACOKINETICS The mechanism of action of topically applied urea is not yet known."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients."],"description":["DESCRIPTION Urea Lotion 35% is a keratolytic emollient which is a gentle, yet potent, tissue softener for skin. Each gram of Urea Lotion 35% contains 35% urea and the following inactive ingredients: caprylic/capric triglyceride, carbomer, cetyl alcohol, cholesterol, disodium EDTA, glycosphingolipids, hydrogenated polydecene, hydroxyethylcellulose, lactic acid, linoleic acid, phospholipids, polysorbate 60, PPG-5 laureth-5, purified water, sodium polyacrylate, sorbitan stearate, triethanolamine, vitamin E, xanthan gum and zinc pyrithione. Urea is a diamide of carbonic acid with the following chemical structure: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply Urea Lotion 35% to affected skin twice per day, or as directed by a physician. Rub in until lotion is completely absorbed."],"effective_time":"20130418","how_supplied":["HOW SUPPLIED Urea Lotion 35% is supplied as a: 7 oz (207 mL) bottle, NDC 0168-0488-07 11 oz (325 mL) bottle, NDC 0168-0488-11 Store at 15°-30° C (59°-86° F). Protect from freezing. Manufactured for: E. FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 Manufactured by: Pegasus Laboratories Pensacola, FL 32514 IL278A R12/08"],"id":"0572f1d5-40dc-437c-9b54-3bbdb299cd83","indications_and_usage":["INDICATIONS AND USES 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, pruritus, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses."],"information_for_patients":["INSTRUCTIONS FOR USE Fougera ® UREA LOTION 35% Rx only In a vehicle containing vitamin E, lactic acid and zinc Steps to help gently thin and soften thick, rough or dry skin seen, to various degrees, In psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema and calluses. For skin: Apply Urea Lotion 35% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed."],"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 Urea Lotion 35% is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 7 oz CONTAINER NDC 0168-0488-07 Fougera® UREA LOTION 35% In a vehicle containing Vitamin E, Lactic Acid and Zinc For Topical Use Only Rx only Net Wt. 7 oz (207 mL) Container Label","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 7 oz CARTON NDC 0168-0488-07 Fougera ® UREA LOTION 35% In a vehicle containing Vitamin E, Lactic Acid and Zinc For Topical Use Only Rx only NET WT. 7 oz (207 mL) Carton Label"],"pharmacokinetics":["PHARMACOKINETICS The mechanism of action of 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 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 reproductive studies are not always predictive of human response, Urea Lotion 35% 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 Urea Lotion 35% is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"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 reproductive studies are not always predictive of human response, Urea Lotion 35% should be given to a pregnant woman only if clearly needed."],"set_id":"464847f1-3e0f-4e9b-9981-16300413e303","spl_product_data_elements":["Urea Urea UREA UREA WATER EDETATE DISODIUM CARBOMER HOMOPOLYMER TYPE C XANTHAN GUM LINOLEIC ACID CHOLESTEROL SORBITAN MONOSTEARATE POLYSORBATE 60 CETYL ALCOHOL ALPHA-TOCOPHEROL TROLAMINE LACTIC ACID PYRITHIONE ZINC"],"spl_unclassified_section":["Rx only For external use only. Not for ophthalmic use."],"version":"3","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}