Label: POVIDONE IODINE PLUS- povidone-iodine gel

  • 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 April 22, 2010

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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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