PVP IODINE- povidone-iodine swab 
HART Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PVP IODINE WIPES

Active Ingredient

Povidone Iodine 10% (equivalent to 1% titratable iodine)

Purpose

Topical Antiseptic

Uses

First aid topical antiseptic to help prevent infection in:

Warnings

For external use only

Do not use

Stop use and ask a doctor if

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away 1-800-222-1222

Directions

Adults and children 12 years of age and over:

Children under 12 years of age:

Inactive Ingredients

Citric Acid, Glyercin, Nonoxynol, Sodium Hydroxide, Water

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PVP IODINE 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0047
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.10 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0047-010 in 1 BOX04/01/1974
1.35 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0047-7100 in 1 BOX04/20/2016
2.35 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/1974
Labeler - HART Health (069560969)
Registrant - HART Health (069560969)
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Province JianErKang Medical530968767manufacture(50332-0047)

Revised: 7/2023
Document Id: eb67274e-2749-4311-99b5-fbd249c82c26
Set id: 06b085dd-934d-40e9-aa0d-2dd9cdccd535
Version: 6
Effective Time: 20230721
 
HART Health