{"active_ingredient":["Active ingredient Hydrocortisone 1%"],"do_not_use":["Do Not Use For the treatment of diaper rash, consult a doctor. With any other Hydrocortisone product unless you have consulted a doctor If you have a vaginal discharge, consult a doctor"],"dosage_and_administration":["Directions Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use and ask a doctor. For External and anal itching in adults: When practical, clean affected area with mild soap and warm water and rinse thoroughly Gently dry by patting or blotting with toilet tissue or a soft cloth before applying For External anal and genital itching in children under 12 years of age: Ask a doctor"],"effective_time":"20260304","id":"4c35f112-b0b8-2efb-e063-6394a90a8f5b","inactive_ingredient":["Inactive ingredients Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water."],"indications_and_usage":["Uses For temporary relief of itching associated with minor skin irritations and rashes ● 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M017"],"brand_name":["Hydrocortisone 1%"],"generic_name":["HYDROCORTISONE"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals Usa Llc"],"nui":["N0000175576","N0000175450"],"package_ndc":["69396-118-09","69396-118-25"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["69396-118"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["106258"],"spl_id":["4c35f112-b0b8-2efb-e063-6394a90a8f5b"],"spl_set_id":["f4d4a56b-b4b7-9a07-e053-2a95a90ad853"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"],"upc":["0850026393767"]},"package_label_principal_display_panel":["LABEL 1016SL GLOBE HYDROCORTISONE CREAM WITHOUT ALOE 0.9G 144CT 073125 CDER","Packaging Globe Hydrocortisone Cream 0.9g 25pks CDER"],"purpose":["Purpose Antipruritic (Anti-Itch)"],"questions":["Questions Call 1-888-296-9067"],"set_id":"f4d4a56b-b4b7-9a07-e053-2a95a90ad853","spl_product_data_elements":["Hydrocortisone 1% Hydrocortisone PHENOXYETHANOL MINERAL OIL GLYCERIN GLYCERYL MONOSTEARATE PETROLATUM WATER HYDROCORTISONE HYDROCORTISONE POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN"],"spl_unclassified_section":["DRUG FACTS","Distributed by: Trifecta Pharmaceuticals USA™ Ft. Lauderdale, FL 33301 USA Online: www.trifecta-pharma.com Reorder No. 1016SL To reorder call: 1-888-296-9067 Fax: 888-878-3609"],"stop_use":["Stop using this product and ask a doctor if conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product. Rectal bleeding occurs"],"storage_and_handling":["Other information ● store at controlled room temperature 20°-25°C ( 68 °- 77 °F) Tamper evident, do not use if packet is torn, cut or opened. Avoid excessive heat and humidity."],"version":"5","warnings":["Warnings For external use only"],"when_using":["When using this product Avoid Contact with the eyes do not exceed the recommended daily dosage unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator."]}