POVIDONE IODINE PLUS (POVIDONE-IODINE) GEL [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]

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POVIDONE IODINE PLUS (POVIDONE-IODINE) GEL [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]
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NDC 50730-8214-8
Set ID 1948e9d0-bd76-4d69-a032-71639c9e81b9
Category HUMAN OTC DRUG LABEL
Packager H and P Industries, Inc. dba Triad Group
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

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

  • PURPOSE

    Antiseptic

  • USES

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

    For external use only.

    Do not use

    • in the eyes
    • on individuals who are allergic or sensitive to iodine
    • as a first aid antiseptic longer than 1 week unless directed by a doctor

    Ask a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns



    Stop use and ask a doctor if

    • irritation and redness develop



    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 15° - 30° C (59° - 86° F)
  • INACTIVE INGREDIENTS

    citric acid, glycerin, hydroxyethylcellulose, sodium hydroxide, water
  • QUESTIONS


  • PACKAGE INFORMATION

    Cat. No. 11-LP14
    NDC 50730-8214-8

    TRIAD Plus

    POVIDONE IODINE
    PREP GEL

    Povidone Iodine, USP
    10% Topical Gel

    • ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
    • For Hospital and Professional use.
    4 Fluid Ounces (118 ml)

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029    Made In USA
    www.triad-group.net

    label

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PLUS 
    povidone-iodine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine0.10 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-8214-8118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2001
    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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