{"active_ingredient":["Active i ngredient s Hydrocortisone Acetate 1%"],"do_not_use":["Do not use if you have a vaginal discharge. Consult a physician."],"dosage_and_administration":["Directions adults and children 12 years and older Apply to external vaginal area not more than 3 to 4 times a day children under 12 years consult a doctor"],"dosage_and_administration_table":["<table><col width=\"319\"/><col width=\"319\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \">adults and children 12 years and older</td><td styleCode=\"Toprule Lrule Rrule \">Apply to external vaginal area not more than 3 to 4 times a day</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">children under 12 years</td><td styleCode=\"Toprule Lrule Rrule \">consult a doctor</td></tr></tbody></table>"],"effective_time":"20241212","id":"6bda1a43-d565-4da6-9c24-bdd05ada4cc2","inactive_ingredient":["Inactive i ngredients: water, cetyl ethylhexanoate, glycerin, PEG-40 hydrogenated castor oil, glyceryl dilaurate, dimethicone, colloidal oatmeal, aloe barbadensis leaf extract, sodium polyacrylate, caprylyl glycol, ceteareth-20, glyceryl oleate, acrylates/C10-30 alkyl acrylate crosspolymer, cyclopentasiloxane, trideceth-6, sodium hydroxide, disodium EDTA, sorbic acid, PEG/PPG-18/18 dimethicone, tocopheryl acetate, maltodextrin, phenoxyethanol."],"indications_and_usage":["Use For temporary external feminine itching."],"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":["Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula"],"generic_name":["HYDROCORTISONE ACETATE"],"is_original_packager":[true],"manufacturer_name":["Combe Incorporated"],"package_ndc":["11509-5101-1"],"product_ndc":["11509-5101"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1039349","1039353"],"spl_id":["6bda1a43-d565-4da6-9c24-bdd05ada4cc2"],"spl_set_id":["9b69fa24-02dd-43e4-a81f-9a37968d7099"],"substance_name":["HYDROCORTISONE ACETATE"],"unii":["3X7931PO74"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Vagisil Sensitive Skin Anti-Itch Creme , 1% Hydrocortisone Net. Wt. 1 oz. (28 g) Vagisil Sensitive Skin Anti-Itch Creme, 1% Hydrocortisone Net. Wt. 1 oz. (28 g)"],"purpose":["Purpose Anti-itch"],"set_id":"9b69fa24-02dd-43e4-a81f-9a37968d7099","spl_product_data_elements":["Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula Hydrocortisone Acetate HYDROCORTISONE ACETATE HYDROCORTISONE WATER CETYL ETHYLHEXANOATE GLYCERIN POLYOXYL 40 HYDROGENATED CASTOR OIL GLYCERYL DILAURATE DIMETHICONE OATMEAL ALOE VERA LEAF SODIUM POLYACRYLATE (2500000 MW) CAPRYLYL GLYCOL POLYOXYL 20 CETOSTEARYL ETHER GLYCERYL OLEATE CARBOMER INTERPOLYMER TYPE A (55000 CPS) CYCLOMETHICONE 5 TRIDECETH-6 SODIUM HYDROXIDE EDETATE DISODIUM SORBIC ACID PEG/PPG-18/18 DIMETHICONE ALPHA-TOCOPHEROL ACETATE MALTODEXTRIN PHENOXYETHANOL"],"spl_unclassified_section":["Vagisil Sensitive Skin A nti-Itch Cr e me Drug Facts"],"stop_use":["Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days."],"version":"4","warnings":["Warnings For e xternal u se o nly Avoid c ontact with eyes Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not use if you have a vaginal discharge. Consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}