Label: PVP IODINE SWABS- povidone-iodine solution
NORTH PVP IODINE SWABS- povidone-iodine solution

  • NDC Code(s): 0498-0118-46, 0498-0128-00, 0498-0128-46
  • Packager: Honeywell Safety Products USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated December 9, 2021

If you are a consumer or patient please visit this version.

  • 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

  • Principal Display Panel

    PVP

  • Honeywell PVP

    Honeywell PVPswab

  • INGREDIENTS AND APPEARANCE
    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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, IncNORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.812503712repack(0498-0118, 0498-0128)