POVI-ONE- povidone-iodine 10% topical liquid 
Elevate Oral Care

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Povi-One

Drug Facts
Active Ingredients

Drug Facts

Uses
Purpose

Uses

Warning For External Use
Do Not Use

Warning For External Use

Stop Use And Ask A Doctor

Stop Use And Ask A Doctor

Keep Out of Reach of Children

Keep Out of Reach of Children

Directions

Directions

Other Information

Other Information

Inactive Ingredients

Inactive Ingredients

Contents

Contents

Questions?

Questions?

Instructions for Use

Instructions for Use

Drug Facts

Drug Facts

Povi-One Soultion
Outside box label

Povi-One Solution

POVI-ONE 
povidone-iodine 10% topical liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0611(NDC:68599-3500)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Colorbrown (liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0611-16 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)03/01/2023
Labeler - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIBusiness Operations
Elevate Oral Care002863526relabel(57511-0611) , repack(57511-0611)

Revised: 10/2023
Document Id: 08f2fbb3-2fcf-508c-e063-6394a90a6091
Set id: f5252b4f-5e14-509e-e053-2995a90a6db8
Version: 2
Effective Time: 20231030
 
Elevate Oral Care