Label: POVIDONE IODINE- 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 February 22, 2010

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  • ACTIVE INGREDIENT

    Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

  • PURPOSE

    Antiseptic

  • USE

    First aid 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 on individuals who are allergic or sensitive to iodine
    • apply over large areas of the body

    Discontinue use and ask a doctor

    • if condition persists or gets worse
    • for use longer than 1 week



    Ask a doctor in case of

    • deep or puncture wounds
    • animal bites
    • 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
    • If bandaged, let dry first
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature 15° - 30° C (59° - 86° F)
  • INACTIVE INGREDIENTS

    citric acid, glycerin, Makon 8, purified water, sodium hydroxide
  • QUESTIONS


  • PACKAGE INFORMATION

    MEDIC®

    NDC 50730-8230-1

    *COMPARE TO THE ACTIVE
    INGREDIENT IN BETADINE    ®

    10% Topical Solution
    Povidone
    Iodine

    For External Use Only

    Helps prevent the risk of
    infection in minor cuts,
    scrapes and burns


    8 FL OZ (236 mL)

    Distributed by Winn-Dixie Stores, Inc.
    Jacksonville, FL 32254
    ©2008 Winn-Dixie Stores, Inc.

    Quality Guaranteed
    1-866-WINN-DIXIE
    www.winn-dixie.com

    *This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark, Betadine®.

    label


  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine0.10 mg  in 1 mL
    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:50730-8230-1236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/06/2007
    Labeler - Triad Group (050259597)
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