{"active_ingredient":["Active ingredient Hydrocortisone 1%"],"do_not_use":["Do not use for the treatment of diaper rash. Consult a doctor."],"dosage_and_administration":["Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product. when first opening the tube, puncture foil seal with top end of cap 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":"20250707","id":"395a1c1c-351c-0fcf-e063-6394a90a3b6e","inactive_ingredient":["Inactive ingredients anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum"],"indications_and_usage":["Uses temporary relief of external anal itching temporary relief of itching associated with minor skin irritations and rashes 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":["M015"],"brand_name":["PREPARATION H SOOTHING RELIEF ANTI-ITCH"],"generic_name":["HYDROCORTISONE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"nui":["N0000175576","N0000175450"],"package_ndc":["0573-0552-11"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["0573-0552"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["310868"],"spl_id":["395a1c1c-351c-0fcf-e063-6394a90a3b6e"],"spl_set_id":["d6148d77-ef6f-4552-b5ba-43b429923f19"],"substance_name":["HYDROCORTISONE"],"unii":["WI4X0X7BPJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 26 g Tube Label PREPARATION H ® soothing RELIEF anti-itch cream HYDROCORTISONE 1% Maximum Strength Without a Prescription Effective Itch Relief No Added Fragrance NET WT 0.9 OZ (26 g) PRINCIPAL DISPLAY PANEL - 26 g Tube Label","PRINCIPAL DISPLAY PANEL - 26 g Tube Carton NEW! PREPARATION H ® soothing RELIEF anti-itch cream HYDROCORTISONE 1% Maximum Strength Without a Prescription Effective Itch Relief No Added Fragrance ONE TUBE / NET WT 0.9 0Z (26 g) PRINCIPAL DISPLAY PANEL - 26 g Tube Carton"],"purpose":["Purpose Anti-itch"],"questions":["Questions or comments? Call weekdays from 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374"],"set_id":"d6148d77-ef6f-4552-b5ba-43b429923f19","spl_product_data_elements":["PREPARATION H SOOTHING RELIEF ANTI-ITCH hydrocortisone ANHYDROUS CITRIC ACID BUTYLATED HYDROXYANISOLE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CETYL ALCOHOL CITRIC ACID MONOHYDRATE EDETATE DISODIUM GLYCERIN GLYCERYL OLEATE GLYCERYL MONOSTEARATE LANOLIN METHYLPARABEN PROPYL GALLATE PROPYLENE GLYCOL PROPYLPARABEN WATER DIMETHICONE 350 SODIUM BENZOATE SODIUM LAURYL SULFATE STEARYL ALCOHOL PETROLATUM XANTHAN GUM HYDROCORTISONE HYDROCORTISONE off-white viscous cream"],"stop_use":["Stop use and ask a doctor if bleeding occurs condition worsens 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 consulted a doctor."],"storage_and_handling":["Other information store at 20–25°C (68–77°F)"],"version":"7","warnings":["Warnings For external use only Do not use for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with the eyes do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition worsens 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 consulted a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid contact with the eyes do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator"]}