PVP IODINE SWABS- povidone-iodine solution 
NORTH PVP IODINE SWABS- povidone-iodine solution 
Honeywell Safety Products USA, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0498-0118 & 0498-0128: PVP Iodine Swabs

Active ingredient

Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

Purpose

First aid antiseptic

Uses

first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • on individuals who are allergic or sensitive to iodine

Ask a doctor before use if you have

  • deep or puncture wounds,
  • animal bites
  • serious burns

When using this product

do not use longer than one wek unless directed by a doctor

Stop use and ask a doctor if

  • conditions persists or gets worse
  • irritation and redness develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

Other information

Inactive ingredients

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

Questions and comments?

800-430-5490

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PVP IODINE SWABS 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.006 g  in 0.6 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHOSPHATE ION (UNII: NK08V8K8HR)  
WATER (UNII: 059QF0KO0R)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0128-4610 in 1 CARTON09/21/2018
1NDC:0498-0128-000.6 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/21/2018
NORTH PVP IODINE SWABS 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.006 g  in 0.6 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHOSPHATE ION (UNII: NK08V8K8HR)  
WATER (UNII: 059QF0KO0R)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0118-4610 in 1 CARTON09/12/2012
10.6 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/12/2012
Labeler - Honeywell Safety Products USA, Inc (118768815)
Registrant - Honeywell Safety Products USA, Inc (118768815)

Revised: 1/2024
Document Id: 0ec9fe98-9972-c588-e063-6394a90a9168
Set id: 0376a2eb-c5e5-4ab9-b44c-ba402e9788c2
Version: 11
Effective Time: 20240112
 
Honeywell Safety Products USA, Inc