{"description":["DESCRIPTION Urea 41% Cream used to soften and moisturize dry, rough, and hyperkeratotic skin."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply Urea 41% Cream to affected area(s) twice daily or as directed by a physician. Rub into the skin until completely absorbed. For nail conditions, apply to diseased or damaged nails twice daily or as directed by a physician."],"effective_time":"20260306","how_supplied":["HOW SUPPLIED Urea 41% Cream is supplied as: 8 oz (227 g) container NDC: 85477-306-27 Dispensed by prescription."],"id":"b128343f-a2d2-416d-b349-d5e39bdc3671","indications_and_usage":["INDICATIONS AND USAGE Urea 41% Cream is indicated 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. It is also indicated for the treatment of hyperkeratotic conditions such as: dry, rough skin dermatitis psoriasis xerosis ichthyosis eczema keratosis pilaris keratosis palmaris keratoderma corns and calluses damaged, ingrown, or devitalized nails"],"openfda":{"brand_name":["Urea 41"],"generic_name":["UREA 41"],"is_original_packager":[true],"manufacturer_name":["Oncora Pharma, LLC"],"package_ndc":["85477-306-27"],"product_ndc":["85477-306"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"spl_id":["b128343f-a2d2-416d-b349-d5e39bdc3671"],"spl_set_id":["ff306984-a52b-48d8-88a8-3a4c72109e63"],"substance_name":["UREA"],"unii":["8W8T17847W"],"upc":["0854770306271"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Urea Cream 41% For dry, rough, cracked, and callused skin. For external use only. Not for ophthalmic use. 8 oz (227 g) Distributed by: Oncora Pharma Dallas, TX 75161 pdp pdp"],"set_id":"ff306984-a52b-48d8-88a8-3a4c72109e63","spl_product_data_elements":["Urea 41 Urea 41 UREA UREA WATER CETEARYL ALCOHOL PROPYLENE GLYCOL CETEARETH-20 PARAFFIN POLYACRYLAMIDE (10000 MW) XANTHAN GUM LAURETH-7 PHENOXYETHANOL ETHYLHEXYLGLYCERIN"],"version":"1","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips, or mucous membranes. Discontinue use and consult a physician if redness, irritation, or sensitivity occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."]}