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

----------

Pove-One

Drug Facts
Active Ingredient

Active Ingredient

Uses

Purpose

Warnings For External Use
Do Not Use

Do Not Use

Stop Use and Ask A Doctor

Stop Use

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 Panel

Drug Facts Panel

Povi-One Solution 0.2ml X 6 Ampules
NDC: 57511-0610-1

Povi-One

POVI-ONE 
povidone-iodine 10% topical liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0610(NDC:0395-2325)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-2 (UNII: U4A966MO25)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorbrown (liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0610-16 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product05/02/202205/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)05/02/202205/02/2022
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIBusiness Operations
Elevate Oral Care002863526relabel(57511-0610) , repack(57511-0610)

Revised: 12/2024
Document Id: 291445d5-3068-e986-e063-6394a90acce3
Set id: d8ca1d1f-f945-480b-e053-2a95a90a096e
Version: 4
Effective Time: 20241212
 
Elevate Oral Care