{"active_ingredient":["Active Ingredient Hydrocortisone 1%"],"do_not_use":["Do Not Use For the treatment of diaper rash, consult a doctor For the external genital itching if you have a vaginal discharge, consult a doctor"],"dosage_and_administration":["Directions Adults and children 2 years and older apply to affected area not more than 3 to 4 times daily. Children under 2 years of age D o not use, consult a doctor For External and anal itching When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly by patting or blotting with toilet tissue or a soft cloth before application of this product. adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily children under 12 years of age with external anal itching: consult a doctor."],"effective_time":"20241104","how_supplied":["HOW SUPPLIED Product: 50090-7428 NDC: 50090-7428-0 28 g in a TUBE / 1 in a BOX"],"id":"4232c9e5-bdff-4b3e-8df4-868d2e8d9f06","inactive_ingredient":["Inactive Ingredients Aloe barbadensis leaf juice, Cetyl alcohol, Edetate Disodium, Methylparaben, Mineral Oil, Mono and di glycerides, petrolatum, Polysorbate 60, Propylene glycol, propylparaben, purified water, sorbitan monostearate."],"indications_and_usage":["Uses For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, oak, sumac soaps detergents cosmetics jewelry external feminine, genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor."],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"openfda":{"application_number":["M017"],"brand_name":["Hydrocortisone with Aloe"],"generic_name":["HYDROCORTISONE"],"manufacturer_name":["A-S Medication Solutions"],"nui":["N0000175576","N0000175450"],"original_packager_product_ndc":["0536-1407"],"package_ndc":["50090-7428-0"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["50090-7428"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["106258"],"spl_id":["4232c9e5-bdff-4b3e-8df4-868d2e8d9f06"],"spl_set_id":["3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"]},"package_label_principal_display_panel":["Hydrocortisone Label Image"],"purpose":["Purpose Anti-Itch"],"set_id":"3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3","spl_product_data_elements":["Hydrocortisone with Aloe Hydrocortisone GLYCERYL MONO AND DIPALMITOSTEARATE EDETATE DISODIUM PROPYLPARABEN SORBITAN MONOSTEARATE PROPYLENE GLYCOL PETROLATUM ALOE BARBADENSIS LEAF EXTRACT CETYL ALCOHOL WATER HYDROCORTISONE HYDROCORTISONE METHYLPARABEN POLYSORBATE 60 MINERAL OIL"],"spl_unclassified_section":["Other Information store at controlled room temperature 20°-25°C (68°-77°F)","Other Information Distributed By: Rugby Laboratories® Indianapolis, IN 46268 www.majorpharmaceuticals.com 1-800-616-2471 This product is not manufactured or distributed by Chattem, Inc. owner of the registered trademark Cortizone 10®"],"stop_use":["Stop using this product and ask a doctor if Conditions worsen symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor."],"version":"1","warnings":["Warnings for external use only avoid contact with eyes do not put this product into the rectum by using fingers or any mechanical device or applicator For External Anal Itching Users: do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding, consult a doctor promptly children under 12 years of age: consult a doctor Before using any medication, read all label directions. Keep this carton as it contains important information"],"when_using":["When using this product avoid contact with the eyes. do not begin the use of any other hydrocortisone product unless you have consulted a doctor for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator."]}