Label: SPLINTER FIRST AID KIT- povidone iodine, kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 23, 2018

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  • Active ingredient

    Povidone iodine 10% (equivalent to 1% titrateable iodine)

  • Purpose

    First aid antiseptic

  • Uses

    • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • Warnings

    For external use only

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens or persists for more than 72 hours
    • irritation and redness develops

    Keep out of reach of children.

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

  • Directions

    • clean the affected area
    • apply1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    • do not use on individuals who are allergic or sensitive to iodine
    • store at controlled temperature 59-86ºF (15-30ºC)
    • do not use if pouch is open or torn
    • discard after each use
  • Inactive ingredients

    nonoxynol 9, water

  • Questions

    1-800-430-5490

  • Principal Display Panel

    Antiseptic Wipe PVP

  • INGREDIENTS AND APPEARANCE
    SPLINTER FIRST AID KIT 
    povidone iodine, kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-9002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-9002-001 in 1 KIT12/29/2017
    11 in 1 POUCH; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 POUCH 1 mL
    Part 1 of 1
    NORTH PVP IODINE WIPE 
    povidone-iodine 10% swab
    Product Information
    Item Code (Source)NDC:0498-0120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0120-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/29/2017
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321pack(0498-9002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical532775194manufacture(0498-0120)
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