{"active_ingredient":["Active Ingredient: Povidone Iodine USP 10%"],"do_not_use":["Do not apply to persons allergic to iodine. Do not use in the eyes. Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns."],"dosage_and_administration":["Directions: Clean the area. Apply product to the operative site prior to surgery."],"effective_time":"20251119","id":"43f8ee7b-b7fb-b4ce-e063-6294a90a2500","inactive_ingredient":["Inactive Ingredients: Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water."],"indications_and_usage":["Use: For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection."],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["505G(a)(3)"],"brand_name":["PVP-I Pouch foil-foil"],"generic_name":["POVIDONE-IODINE"],"is_original_packager":[true],"manufacturer_name":["Dukal LLC"],"nui":["N0000175486","M0011640"],"package_ndc":["65517-0035-1","65517-0035-2"],"pharm_class_cs":["Iodine [CS]"],"pharm_class_epc":["Antiseptic [EPC]"],"product_ndc":["65517-0035"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["312564"],"spl_id":["43f8ee7b-b7fb-b4ce-e063-6294a90a2500"],"spl_set_id":["45aefabf-5283-411a-b509-749977635938"],"substance_name":["POVIDONE-IODINE"],"unii":["85H0HZU99M"]},"other_safety_information":["Other Information: 1% titratable iodine, for hospital or professional use only. Store at ambient temperatures."],"package_label_principal_display_panel":["Principal Display Panel - 3/4 oz Pouch Label Dukal Povidone-Iodine 3/4 Fluid Ounce Solution Sterile Antiseptic Drug Facts Active Ingredient Purpose Povidone Iodine USP 10% Antiseptic Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection. Sterile unless package is damaged or opened. 0.75 fl oz (22.5 ml) - 2 - NDC 6551-0035-1 - REF 885 885","Principal Display Panel - 1 oz Pouch Label Dukal Povidone-Iodine 1 Fluid Ounce Solution Sterile Antiseptic Drug Facts Active Ingredient Purpose Povidone Iodine USP 10% Antiseptic Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection. Sterile unless package is damaged or opened. 1 fl oz (29.5 ml) - 2 - NDC 6551-0035-2 - REF 886 886"],"purpose":["Purpose: Antiseptic"],"set_id":"45aefabf-5283-411a-b509-749977635938","spl_product_data_elements":["PVP-I Pouch foil-foil Povidone-iodine GLYCERIN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) NONOXYNOL-10 CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE WATER C12-20 ALKYL GLUCOSIDE POTASSIUM IODIDE POVIDONE-IODINE IODINE"],"stop_use":["Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs. Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation."],"version":"13","warnings":["Warnings: For external use only. Do not apply to persons allergic to iodine. Do not use in the eyes. Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns. Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs. Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation. Keep out of reach of children If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away."]}