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.

  • clean affected area
  • apply to affected area 1 to 3 times daily
  • may be covered with a sterile bandage
  • discard swab after single use

Other information

  • store at room temperature away from light
  • keep from freezing or excessive heat
  • do not use if package is torn or open

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 (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)

Revised: 12/2022
Document Id: f0ec5c76-3346-d633-e053-2995a90a05fd
Set id: 0376a2eb-c5e5-4ab9-b44c-ba402e9788c2
Version: 10
Effective Time: 20221228
 
Honeywell Safety Products USA, Inc