Label: POVIDONE IODINE PLUS- povidone-iodine ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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
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