{"active_ingredient":["Active Ingredient Hydrocortisone 1%"],"do_not_use":["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 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":"20250508","id":"34a11b3c-74d6-e242-e063-6294a90a7765","inactive_ingredient":["Inactive Ingredients Aloe barbadensis leaf juice, Cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, glycerin, Glycerol Stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2-Phenoxyethanol, Polysorbate 80, Propylene Glycol, purified water, Stearic Acid, Trisodium citrate dihydrate, Vitamin E."],"indications_and_usage":["Uses For temporarily rellief of itching associated with minor skin irritations, inflammation and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy poison oak poison sumac soaps detergents cosmetics jewelry temporarily relieves external anal and genital itching Other use 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 immediately."],"openfda":{"application_number":["M017"],"brand_name":["Hydrocortisone Cream"],"generic_name":["HYDROCORTISONE"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals USA"],"nui":["N0000175576","N0000175450"],"package_ndc":["69396-096-16"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["69396-096"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["106258"],"spl_id":["34a11b3c-74d6-e242-e063-6294a90a7765"],"spl_set_id":["d57a59fb-c8f2-f73b-e053-2995a90a4cdb"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"],"upc":["0850026393378"]},"package_label_principal_display_panel":["Package Label 4075 GLOBE HYDROCORTISONE CREAM WITH ALOE 16OZ REV08 042725 CDER"],"purpose":["Purpose Anti-Itch"],"questions":["Questions Call 1-888-296-9067"],"set_id":"d57a59fb-c8f2-f73b-e053-2995a90a4cdb","spl_product_data_elements":["Hydrocortisone Cream Hydrocortisone EDETIC ACID MALTODEXTRIN GINGER OIL POLYSORBATE 80 STEARIC ACID METHYL GLUCETH-20 3-METHYLPENTADECANE PHENOXYETHANOL ETHYLPARABEN DIMETHICONE GLYCERIN GLYCERYL MONOSTEARATE PETROLATUM ALOE VERA LEAF CETYL ALCOHOL WATER HYDROCORTISONE HYDROCORTISONE TRISODIUM CITRATE DIHYDRATE METHYLPARABEN PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL"],"spl_unclassified_section":["Other Information store at controlled room temperature 20°- 25°C (68°-77°F)","Other Information Distributed By: Trifecta Pharmaceuticals USA® 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com This product is not manufactured or distributed by Chattem, Inc. distributor of Cortizone-10."],"stop_use":["Stop using this product and ask a doctor Conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor. Rectal bleeding occurs"],"version":"7","warnings":["Warnings for external use only"],"when_using":["When using this product When using this product avoid contact with the 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."]}