{"active_ingredient":["ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch"],"do_not_use":["for the treatment of diaper rash. Consult a doctor."],"dosage_and_administration":["D IRECTIONS Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily for up to 7 days. Children under 2 years of age: do not use, consult a physician"],"effective_time":"20250626","id":"387b74cf-5783-b70c-e063-6294a90a7248","inactive_ingredient":["INACTIVE INGREDIENTS coconut oil, shea butter, cera microcristallina, tocopherol, phenoxyethanol"],"indications_and_usage":["USES For the temporary relief of itching associated with minor skin irritations and rashes due to: Eczema Cosmetics Psoriasis Seborrheic Dermatitis Other uses of this product should be only under the advice and supervision of a physician."],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{"application_number":["M017"],"brand_name":["MediBalm"],"generic_name":["HYDROCORTISONE"],"is_original_packager":[true],"manufacturer_name":["BalmRx, LLC"],"nui":["N0000175576","N0000175450"],"package_ndc":["85529-204-01"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["85529-204"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["203105"],"spl_id":["387b74cf-5783-b70c-e063-6294a90a7248"],"spl_set_id":["324dd151-84c5-3e2f-e063-6394a90a569d"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"],"upc":["0197644745715"]},"package_label_principal_display_panel":["PDP"],"purpose":["ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch"],"recent_major_changes":["Removed \"Warnings and Precautions section\" Added \"OTC - Purpose section\" - \"ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch\" Added \"Warnings section\" - \"For external use only. Avoid contact with eyes.\" Added \"OTC - Stop use section\" - \"and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor.\" Added \"OTC - Do not use section\" - \"for the treatment of diaper rash. Consult a doctor.\" Added \"OTC - Keep out of reach of Children section\""],"set_id":"324dd151-84c5-3e2f-e063-6394a90a569d","spl_product_data_elements":["MediBalm Hydrocortisone MICROCRYSTALLINE WAX HYDROCORTISONE HYDROCORTISONE PHENOXYETHANOL TOCOPHEROL COCOS NUCIFERA (COCONUT) OIL BUTYROSPERMUM PARKII (SHEA) BUTTER"],"stop_use":["and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor."],"storage_and_handling":["OTHER INFORMATION Store at 59-80 F (15-30 C). Protect from freezing."],"version":"3","warnings":["For external use only. Avoid contact with eyes."]}