{"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":"20260422","id":"e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4","inactive_ingredient":["Inactive ingredients Ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl 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"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"nui":["N0000175576","N0000175450"],"original_packager_product_ndc":["69396-050"],"package_ndc":["68788-4109-2"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["68788-4109"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["106258"],"spl_id":["e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4"],"spl_set_id":["e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"]},"package_label_principal_display_panel":["Packaging Hydrocortisone 1% cream"],"purpose":["Purpose Anti-Itch"],"set_id":"e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4","spl_product_data_elements":["Hydrocortisone 1% Hydrocortisone METHYLPARABEN MINERAL OIL SORBITAN MONOSTEARATE CETYL ALCOHOL PETROLATUM WATER HYDROCORTISONE HYDROCORTISONE PROPYLENE GLYCOL POLYSORBATE 60 PROPYLPARABEN EDETATE DISODIUM GLYCERYL MONO- AND DIPALMITOSTEARATE"],"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 Relabeled By: Preferred Pharmaceuticals Inc. 68788-4109-2"],"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":"1","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."]}