{"active_ingredient":["Active ingredient Hydrocortisone 1.0%"],"do_not_use":["Do not use for the treatment of diaper rash in eyes for feminine itching if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days with any other Hydrocortisone product unless you have consulted a doctor"],"dosage_and_administration":["Directions: for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily children under 2 years of age: do not use, consult a doctor adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product children under 12 years of age: for external anal itching, consult a doctor"],"effective_time":"20240207","id":"10d3fc91-82ae-e8eb-e063-6394a90ae87b","inactive_ingredient":["Inactive ingredients: emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax"],"indications_and_usage":["Uses: for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes 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 right away."],"openfda":{"application_number":["M017"],"brand_name":["Hydrocortisone"],"generic_name":["HYDROCORTISONE"],"is_original_packager":[true],"manufacturer_name":["Safetec of America, Inc."],"nui":["N0000175576","N0000175450"],"package_ndc":["61010-5800-1","61010-5800-3","61010-5800-2","61010-5800-4"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["61010-5800"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["106258"],"spl_id":["10d3fc91-82ae-e8eb-e063-6394a90ae87b"],"spl_set_id":["da2b3b2c-11e0-401b-bbd2-d019271d1b3d"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label Safetec 1% Hydrocortisone Cream™ 0.9 g (1/32 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077 PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label","PRINCIPAL DISPLAY PANEL – Box Label NDC 61010-5800-2 Safetec First Aid 1% Hydrocortisone Cream For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation, or Rashes Reorder no. 53110 To reorder: Call: 1-800-456-7077 Fax: 716-895-2969 Online: www.safetec.com PRINCIPAL DISPLAY PANEL – Box Label","PRINCIPAL DISPLAY PANEL – 10 Packet Box Label Safetec ® FIRST AID Hydrocortisone Cream 1% Hydrocortisone for relief from itching, inflammation, and rashes 10 Packets Each Packet Net Wt. 0.9g Made in USA Reorder no. 53108 PRINCIPAL DISPLAY PANEL – 10 Packet Box Label"],"purpose":["Purpose Anti-itch"],"questions":["Questions or Comments? 1-800-456-7077 Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 . 800-456-7077 www.safetec.com"],"set_id":"da2b3b2c-11e0-401b-bbd2-d019271d1b3d","spl_product_data_elements":["Hydrocortisone Hydrocortisone ALCOHOL METHYLPARABEN MINERAL OIL PARAFFIN PETROLATUM PROPYLPARABEN WATER CETOSTEARYL ALCOHOL POLYSORBATE 60 PEG-150 DISTEARATE STEARETH-20 HYDROCORTISONE HYDROCORTISONE"],"spl_unclassified_section":["Drug Facts","Other information: store at room temperature (do not freeze) do not use any opened or torn packets"],"version":"5","warnings":["Warnings: For external use only Do not use for the treatment of diaper rash in eyes for feminine itching if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days with any other Hydrocortisone product unless you have consulted a doctor KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away."]}