{"active_ingredient":["Active Ingredient Povidone-Iodine 10% w/v"],"do_not_use":["Do not use Do not use if allergic to iodine in the eyes"],"dosage_and_administration":["Directions Clean the area. apply locally as needed"],"effective_time":"20241115","id":"26edf53b-4ba3-a69b-e063-6294a90a1769","inactive_ingredient":["Inactive ingredients Citric Acid, Glycerol, Nonoxynol-9, Purified Water USP, Sodium Hydroxide, Sodium Phosphate Dibasic"],"indications_and_usage":["Use Antiseptic skin preparation. Helps reduce bacteria that potentially can cause skin infection."],"keep_out_of_reach_of_children":["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":["505G(a)(3)"],"brand_name":["Saninta 10% Povidone-Iodine"],"generic_name":["POVIDONE-IODINE SOLUTION"],"is_original_packager":[true],"manufacturer_name":["Lernapharm"],"nui":["N0000175486","M0011640"],"package_ndc":["68356-601-01","68356-601-02","68356-601-03"],"pharm_class_cs":["Iodine [CS]"],"pharm_class_epc":["Antiseptic [EPC]"],"product_ndc":["68356-601"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["26edf53b-4ba3-a69b-e063-6294a90a1769"],"spl_set_id":["1275efa3-0602-2f17-e063-6394a90ac56e"],"substance_name":["POVIDONE-IODINE"],"unii":["85H0HZU99M"],"upc":["0896180012519","0896180012496","0896180012502"]},"other_safety_information":["Avoid pooling beneath patient Avoid pooling beneath patient"],"package_label_principal_display_panel":["Package Label - Principal Display Panel NDC: 68356-601-01 / 68356-601-601-02 / 68356-601-03 Product # 601-01 / 601-02 / 601-03 Hold upright [Tear here and pour] [Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone-iodine solution] [Tear open] Saninta Antiseptic Solution 10% w/v Povidone-Iodine Solution 10% Povidone-Iodine [0.75 Fl. oz (22.5 mL)] [0.5 Fl. oz (15 mL)] Do Not Reuse multiple-use cross-through logo UPC Code Manufactured by: Lernapharm (LORIS) Inc. 2323 HALPERN, MONTREAL QUEBEC, CANADA H4S 1S3 Made in Canada LOT #: XXXX EXP.: MM/YYYY image of 68356-601-01 label image of 68356-601-02 image of 68356-601-03 label"],"purpose":["Purpose Antiseptic"],"questions":["Questions or Comments? Questions or Comments? Tel.: 1-866-322-4634, weekdays between 8:00 am and 4:00 pm EST"],"set_id":"1275efa3-0602-2f17-e063-6394a90ac56e","spl_product_data_elements":["Saninta 10% Povidone-Iodine Povidone-Iodine Solution WATER GLYCERIN NONOXYNOL-9 SODIUM HYDROXIDE SODIUM PHOSPHATE DIBASIC DIHYDRATE ANHYDROUS CITRIC ACID POVIDONE-IODINE IODINE"],"stop_use":["Stop use and ask a doctor Stop use and ask a doctor if injuries are deep puncture wounds or serious burns redness, irritation, swelling or pain persists or increases infection occurs"],"storage_and_handling":["Other Information 1% titratable iodine not made with natural rubber latex for hospital or professional use only Store at room temperature between 59-86ºF (15 - 30ºC). Avoid freezing and excessive heat above 40ºC (104ºF)."],"version":"2","warnings":["Warnings For external use only. Do not use Do not use if allergic to iodine in the eyes Stop use and ask a doctor Stop use and ask a doctor if injuries are deep puncture wounds or serious burns redness, irritation, swelling or pain persists or increases infection occurs Avoid pooling beneath patient Avoid pooling beneath patient 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."]}