POVI-ONE- povidone-iodine 10% topical liquid

Povi-One by

Drug Labeling and Warnings

Povi-One by is a Otc medication manufactured, distributed, or labeled by Elevate Oral Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients

Uses Purpose

Warning For External Use Do Not Use

Stop Use And Ask A Doctor

Keep Out of Reach of Children

Directions

Other Information

Inactive Ingredients

Contents

Questions?

Instructions for Use

Drug Facts

Povi-One Soultion Outside box label

INGREDIENTS AND APPEARANCE

POVI-ONE 
povidone-iodine 10% topical liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57511-0611(NDC:68599-3500)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown (liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57511-0611-1	6 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	03/01/2023

Labeler - Elevate Oral Care (002863526)

Establishment
Name	Address	ID/FEI	Business Operations
Elevate Oral Care		002863526	relabel(57511-0611) , repack(57511-0611)