{"active_ingredient":["Active Ingredient Hydrocortisone 1%"],"do_not_use":["Do not use this product and ask a doctor If you have a vaginal discharge before treating diaper rash before using on children under 2 years of age"],"dosage_and_administration":["Directions When practical, cleanse 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 adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a doctor"],"effective_time":"20250508","id":"34a27d85-dac3-2169-e063-6294a90ae708","inactive_ingredient":["Inactive Ingredients Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecannol, petrolatum, purified water, sodium dodecyl sulfate"],"indications_and_usage":["Uses Temporarily relieves 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 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 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":["69396-028-01","69396-028-02","69396-028-44","69396-028-33"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["69396-028"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["106258"],"spl_id":["34a27d85-dac3-2169-e063-6294a90ae708"],"spl_set_id":["4c96ec41-841c-322b-e054-00144ff8d46c"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"],"upc":["0040232381461"]},"package_label_principal_display_panel":["Package Label 4040 GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 042525 CDER","Label 404004-FBA GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 4PK_BOX 042525 CDER","Package Label 404003-FBA GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 3PK_BOX 042525 CDER"],"purpose":["Purpose Anti-Itch"],"set_id":"4c96ec41-841c-322b-e054-00144ff8d46c","spl_product_data_elements":["Hydrocortisone Cream Hydrocortisone POLYSORBATE 60 EDETATE DISODIUM WATER SORBITAN STEARATE PETROLATUM ALOE VERA LEAF HYDROCORTISONE HYDROCORTISONE CETYL ALCOHOL GLYCERYL MONO- AND DIPALMITOSTEARATE METHYLPARABEN MINERAL OIL PROPYLENE GLYCOL PROPYLPARABEN"],"spl_unclassified_section":["Other Information to open; unscrew cap and pull tab to remove foil seal if seal has been broken, do not use this product. Return product to the store where you bought it store at controlled room temperature 15°-30°C (59°-86°F) see carton or tube crimp for lot number and expiration date","Other Information Distributed By: Trifecta Pharmaceuticals USA® 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com 1-888-296-9067"],"stop_use":["Stop using this product and ask a doctor in case of bleeding if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days before you begin using any other hydrocortisone product"],"version":"11","warnings":["Warnings for external use only avoid contact with eyes do not put this product into the rectum by using fingers or any mechanical device or applicator For External Anal Itching Users: do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding, consult a doctor promptly children under 12 years of age: consult a doctor Before using any medication, read all label directions. Keep this carton as it contains important information"]}