TRIADINE WHIRLPOOL (POVIDONE-IODINE) SOLUTION [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]

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TRIADINE WHIRLPOOL (POVIDONE-IODINE) SOLUTION [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]
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NDC 50730-8428-6
Set ID 3f9e9861-91e1-4ef5-a41a-f389c16ebdfb
Category HUMAN OTC DRUG LABEL
Packager H and P Industries, Inc. dba Triad Group
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333
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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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