Label: TRIADINE WHIRLPOOL- povidone-iodine solution

  • 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 December 14, 2009

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  • ACTIVE INGREDIENT

    Povidone Iodine,10% (Equivalent to 1% titratable iodine)

  • PURPOSE

    Antiseptic

  • USES

    • Health-care antiseptic for preparation of the skin prior to surgery
    • First id antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.
  • WARNINGS

    For external use only.

    Do not use

    • in the eyes
    • use as a first aid antiseptic for longer than one week
    • use on individuals who are allergic or sensitive to iodine
    • apply over large areas of the body

    Ask a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns



    Stop use and ask a doctor

    • if condition persists or gets worse
    • if irritation and redness develop and persist for over 72 hours.



    Keep out of reach of children

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

  • DIRECTIONS

    For preparation of the skin prior to surgery:
    • apply to the operative site prior to surgery
    As a first aid antiseptic
    • 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
    • if bandaged, let dry first
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature 20° - 25° C (68° - 77° F)
  • INACTIVE INGREDIENTS

    citric acid, glycerin, nonoxynol-9, sodium hydroxide, water
  • QUESTIONS


  • LABEL INFORMATION

    Triad

    Cat. No. 10-8428
    NDC 50730-8428-6


    TRIADINE
    POVIDONE-IODINE, USP
    WHIRLPOOL CONCENTRATE
    10% Solution

    Antiseptic / Germicide

    For general antiseptic use in Whirlpool or other hydrotherapy tanks.

    For External Use Only!


    128 Fluid Ounces (3.785 L)


    label


  • INGREDIENTS AND APPEARANCE
    TRIADINE WHIRLPOOL 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8428
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.10 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-8428-63.785 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/21/1985
    Labeler - 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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