PVP IODINE SWABS (POVIDONE-IODINE) SOLUTION NORTH PVP IODINE SWABS (POVIDONE-IODINE) SOLUTION [HONEYWELL SAFETY PRODUCTS USA, INC]

PVP IODINE SWABS (POVIDONE-IODINE) SOLUTION NORTH PVP IODINE SWABS (POVIDONE-IODINE) SOLUTION [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-0118-46, 0498-0128-00, 0498-0128-46
Set ID 0376a2eb-c5e5-4ab9-b44c-ba402e9788c2
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, Inc
Generic Name
Product Class
Product Number
Application Number
  • 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, Inc079287321pack(0498-0118, 0498-0128)

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