Povi-One by Elevate Oral Care Pove-One

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]

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

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Pove-One

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

Questions?

Instructions For Use:

Drug Facts Panel

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

POVI-ONE 
povidone-iodine 10% topical liquid

Product 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)

Revised: 12/2024

Document Id: 291445d5-3068-e986-e063-6394a90acce3

34390-5

Set id: d8ca1d1f-f945-480b-e053-2a95a90a096e

Version: 4

Effective Time: 20241212