{"active_ingredient":["Active ingredient Hydrocortisone 1%"],"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, consult a doctor. For External and anal itching: Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product. Children: under 12 years of age with external anal itching: consult a doctor."],"effective_time":"20241218","id":"299056d9-3089-2129-e063-6394a90a804a","inactive_ingredient":["Inactive ingredients Ethylparaben, glycerin, glyceryll monostearate, mineral oil, stearyl alcohol, petrolatum, purified water, sodium lauryl sulfate"],"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 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":["69396-055-01"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["69396-055"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["106258"],"spl_id":["299056d9-3089-2129-e063-6394a90a804a"],"spl_set_id":["9ef5a3b2-c36f-162f-e053-2995a90ae2b0"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"],"upc":["0860001004939"]},"package_label_principal_display_panel":["Packaging globe hydrocortisone 1oz"],"purpose":["Purpose Anti-Itch"],"set_id":"9ef5a3b2-c36f-162f-e053-2995a90ae2b0","spl_product_data_elements":["Hydrocortisone 1% Hydrocortisone ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE STEARYL ALCOHOL MINERAL OIL PETROLATUM WATER SODIUM LAURYL SULFATE HYDROCORTISONE HYDROCORTISONE"],"spl_unclassified_section":["DRUG FACTS","Distributed by: Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL 33301 USA Product of PRC 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 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."],"storage_and_handling":["Other information ● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)"],"version":"3","warnings":["Warnings For external use only Do not Use: For the treatment of a diaper rash, consult with doctor For external genital itching if you have a vaginal discharge, consult doctor"],"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 and consult a doctor. do not put this product into the rectum by using fingers or any medicated device or applicator."]}