{"active_ingredient":["Active ingredient Pramoxine hydrochloride 1% (w/w)","Active ingredient Pramoxine hydrochloride 1% (w/w)"],"dosage_and_administration":["Directions adults and children 12 years and older Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush. children under 12 years consult a doctor","Directions adults and children 12 years and older Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush. 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 \">Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush.</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>","<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 \">Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. Do not flush.</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":"d52bff6a-9386-4ff7-a2ff-bef4a6ad07f8","inactive_ingredient":["Inactive ingredients water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin","Inactive ingredients water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin"],"indications_and_usage":["Use temporarily relieves itching","Use Temporarily relieves 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.","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 Medicated Wipes Maximum Strength"],"generic_name":["PRAMOXINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Combe Incorporated"],"package_ndc":["11509-5035-1","11509-5058-1"],"product_ndc":["11509-5035","11509-5058"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1039541","1039550"],"spl_id":["d52bff6a-9386-4ff7-a2ff-bef4a6ad07f8"],"spl_set_id":["b848f53d-8aea-4efe-aa2c-009d5121fc33"],"substance_name":["PRAMOXINE HYDROCHLORIDE"],"unii":["88AYB867L5"]},"other_safety_information":["Other information store at room temperature discard within 2 months of opening"],"package_label_principal_display_panel":["Principal Display Panel Maximum Strength Vagisil ® Medicated Anti-Itch Wipes Instant Relief From Intense Itch Gynecologist Tested Clinically Tested On-the-go relief With Aloe & Vitamin E Patented Odor Block Technology 12 individually wrapped disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm) Maximum Strength Vagisil® Medicated Anti-Itch Wipes Instant Relief From Intense Itch Gynecologist Tested Clinically Tested • On-the-go relief • With Aloe & Vitamin E • Patented Odor Block Technology 12 individually wrapped disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)","Principal Display Panel Vagisil ® Maximum Strength Medicated Anti-Itc h Wipes Gynecologist Tested Instant Relief From Intense Itch With Aloe & Vitamin E Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm) Principal Display Panel Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm) Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)"],"purpose":["Purpose External analgesic","Purpose External analgesic"],"set_id":"b848f53d-8aea-4efe-aa2c-009d5121fc33","spl_product_data_elements":["VAGISIL Anti-Itch Medicated Wipes Maximum Strength pramoxine hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER POLYSORBATE 20 GLYCERIN PHENOXYETHANOL DISODIUM COCOAMPHODIACETATE TRIETHANOLAMINE COCOYL GLUTAMATE ETHYLPARABEN EDETATE DISODIUM METHYLPARABEN PEG-7 GLYCERYL COCOATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE, DL- MALTODEXTRIN VAGISIL Anti-Itch Medicated Wipes Maximum Strength pramoxine hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER POLYSORBATE 20 GLYCERIN PHENOXYETHANOL DISODIUM COCOAMPHODIACETATE TRIETHANOLAMINE COCOYL GLUTAMATE ETHYLPARABEN EDETATE DISODIUM METHYLPARABEN PEG-7 GLYCERYL COCOATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE, DL- MALTODEXTRIN"],"spl_unclassified_section":["VAGISIL Anti-Itch Medicated Wipes Drug Facts","VAGISIL Maximum Strength Medicated Anti-Itch W ipes Drug Facts"],"stop_use":["Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days","Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days"],"version":"9","warnings":["Warnings For external use only Avoid contact with eyes","Warnings For external use only Avoid contact with eyes"]}