Label: POVI-ONE- povidone-iodine 10% topical liquid
- NDC Code(s): 57511-0610-1
- Packager: Elevate Oral Care
- This is a repackaged label.
- Source NDC Code(s): 0395-2325
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2024
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- Drug Facts Active Ingredient
- Uses
- Warnings For External Use Do Not Use
- Stop Use and Ask A Doctor
- Keep Out of Reach of Children
- Directions
- Other Information
- Inactive Ingredients
- Contents
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- Instructions For Use:
- Drug Facts Panel
- Povi-One Solution 0.2ml X 6 Ampules NDC: 57511-0610-1
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INGREDIENTS AND APPEARANCE
POVI-ONE
povidone-iodine 10% topical liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57511-0610(NDC:0395-2325) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-2 (UNII: U4A966MO25) WATER (UNII: 059QF0KO0R) Product Characteristics Color brown (liquid) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57511-0610-1 6 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 05/02/2022 05/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 05/02/2022 05/02/2022 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 relabel(57511-0610) , repack(57511-0610)
