{"active_ingredient":["Active ingredient Hydrocortisone 1%"],"do_not_use":["Do not use ■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor."],"dosage_and_administration":["Directions ■ for itching of skin irritation, inflammation, and rashes: ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor ■ for external anal and genital itching, adults: ■ when practical, clean the 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 ■ apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor"],"effective_time":"20250801","id":"cb74d908-48c8-4ef2-982b-a4b05a69ae0c","inactive_ingredient":["In active ingredients alcohol denat. (15%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, sodium citrate, water"],"indications_and_usage":["Use s ■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should only be 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 right away."],"openfda":{"application_number":["M017"],"brand_name":["Cortizone 10 Cooling"],"generic_name":["HYDROCORTISONE"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"nui":["N0000175576","N0000175450"],"package_ndc":["41167-0033-2"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["41167-0033"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["198706","846161"],"spl_id":["cb74d908-48c8-4ef2-982b-a4b05a69ae0c"],"spl_set_id":["14d9fce2-9f54-4204-83cb-161de8a303f0"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL MA X IMUM STRENGTH Cortizone 10 COOLING ITCH RELIEF GEL 1% Hydrocortisone Anti-Itch Gel Net wt 1 oz (28 g) MAXIMUM STRENGTH Cortizone 10 COOLING ITCH RELIEF GEL 1% Hydrocortisone Anti-Itch Gel Net wt 1 oz (28 g)"],"purpose":["Purpose Anti-itch"],"set_id":"14d9fce2-9f54-4204-83cb-161de8a303f0","spl_product_data_elements":["Cortizone 10 Cooling Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALCOHOL ALOE VERA LEAF OAT DIMETHICONE EDETATE DISODIUM ANHYDROUS GLYCERIN HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) ISOHEXADECANE MALTODEXTRIN MENTHYL LACTATE, (-)- METHYL GLUCETH-20 METHYLPARABEN POLYSORBATE 60 PPG-3 BENZYL ETHER MYRISTATE PROPYLPARABEN SODIUM CITRATE, UNSPECIFIED FORM WATER"],"spl_unclassified_section":["Cortizone 10 Cooling Gel Drug Facts"],"stop_use":["Stop use and ask a doctor if ■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor ■ rectal bleeding occurs"],"version":"4","warnings":["Warnings For external use only Do not use ■ in the genital area if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor. When using this product ■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if ■ condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor ■ rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product ■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator"]}