{"active_ingredient":["Active Ingredient Miconazole Nitrate 2%"],"do_not_use":["Do not use on children under 2 years of age except under supervision of doctor."],"dosage_and_administration":["Directions Clean and dry the affected area. Cover the affected area with a thin layer twice a day (a.m. and p.m.) on skin, under nails and surrounding cuticle areas. Supervise children in the use of this product. For athlete's foot and ringworm use daily for four (4) weeks. This product is not effective on scalp or nails."],"effective_time":"20251030","id":"0892f504-c8a8-4aff-9901-223635b876c2","inactive_ingredient":["Inactive Ingredients Benzyl Alcohol, Glacial Acetic Acid, Isopropyl Alcohol, Laureth-4, Purified Water and Sodium Hydroxide Solution."],"indications_and_usage":["Uses Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) For effective relief of itchy, scaly skin between the toes."],"keep_out_of_reach_of_children":["Keep out of the reach of children. If swallowed, get medical help or contact poison control center immediately."],"openfda":{"application_number":["M005"],"brand_name":["Azolen"],"generic_name":["MICONAZOLE NITRATE"],"is_original_packager":[true],"manufacturer_name":["Stratus Pharmaceuticals, Inc."],"package_ndc":["58980-818-10"],"product_ndc":["58980-818"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["998525"],"spl_id":["0892f504-c8a8-4aff-9901-223635b876c2"],"spl_set_id":["9c2574f3-3be4-405a-9c87-943dc6ef8777"],"substance_name":["MICONAZOLE NITRATE"],"unii":["VW4H1CYW1K"],"upc":["0358980818109"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Carton NDC 58980-818-10 AZOLEN ™ TINCTURE (MICONAZOLE NITRATE USP, 2%) TOPICAL ANTIFUNGAL Distributed by: STRATUS NET VOL.: 1.0 FL OZ (29.57 mL) Principal Display Panel - 29.57 mL Bottle Carton"],"purpose":["Purpose Topical Antifungal"],"questions":["Questions? 1-800-442-7882"],"set_id":"9c2574f3-3be4-405a-9c87-943dc6ef8777","spl_product_data_elements":["Azolen Miconazole Nitrate Miconazole Nitrate Miconazole Water Benzyl Alcohol Acetic Acid Isopropyl Alcohol Laureth-4 Sodium Hydroxide"],"spl_unclassified_section":["Drug Facts","For more information, see enclosed package insert.","Distributed by: STRATUS PHARMACEUTICALS INC 12379 SW 130th Street Miami, Florida 33186"],"stop_use":["If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor."],"storage_and_handling":["Other Information Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature."],"version":"4","warnings":["WARNINGS For external use only. Do not use on children under 2 years of age except under supervision of doctor. Avoid contact with eyes. If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor. Keep out of the reach of children. If swallowed, get medical help or contact poison control center immediately."],"when_using":["Avoid contact with eyes."]}