Label: POVIDONE IODINE PLUS- povidone-iodine ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 30, 2009

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  • ACTIVE INGREDIENT

    Povidone Iodine USP 10% (equivalent to 1% titratable iodine)

  • PURPOSE

    Antiseptic

  • USE

    First Aid Antiseptic to help prevent infection in minor cuts, scrapes and burns
  • WARNINGS

    For external use only.

    Do not use

    • in the eyes or over large areas of the body
    • longer than 1 week unless directed by a doctor




    Stop use and ask a doctor

    • if condition persists or gets worse
    • in case of deep puncture wounds, animal bites or serious burns



    Keep out of reach of children

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

  • DIRECTIONS

    Clean the affected area. Apply a small amount of this product to the area 1-3 times daily. May be covered with a sterile bandage.
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature 15° - 30° C (59° - 86° F)
  • INACTIVE INGREDIENTS

    glycerin, PEG-300, PEG-1450, propylene glycol
  • QUESTIONS


  • PACKAGE INFORMATION

    TRIAD

    Cat. No. 11-OP01
    NDC 50730-8201-8


    POVIDONE IODINE
    OINTMENT
    10% Povidone Iodine, USP
    (equivalent to 1% titratable iodine)

    • First Aid Antiseptic
    • For Hospital and Professional Use Only
    Triad Group, Inc.
    300 West North Shore Drive
    Hartland, WI 53029

    www.triad-group.net

    Net Wt. 1 gram

    FOIL




  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PLUS 
    povidone-iodine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.10 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    glycerin (UNII: PDC6A3C0OX)  
    polyethylene glycol 300 (UNII: 5655G9Y8AQ)  
    polyethylene glycol 1450 (UNII: OJ4Z5Z32L4)  
    propylene glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-8201-81 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2001
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture