POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [KMART CORPORATION]

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POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [KMART CORPORATION]
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NDC 49738-050-34
Set ID 5bdac950-11b8-483e-a40e-0f2bca294d02
Category HUMAN OTC DRUG LABEL
Packager Kmart Corporation
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Povidone Iodine USP, 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, nonoxynol-8, purified water, sodium hydroxide
  • QUESTIONS


  • LABEL INFORMATION

    Compare to active ingredient of Betadine® Solution*

    NDC 49738-050-34

    AMERICAN FARE

    POVIDONE-
    IODINE
    SOLUTION

    • First Aid Antiseptic
    • Kills germs in minor burns, cuts and scrapes
    8 fl. oz. (236 mL)


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

    If you are not completely satisfied with this or any American Fare product, please call 1-800-842-7886.

    Distributed by:
    Kmart Corporation
    Hoffman Estates, IL 60179
    Made in USA

    label



  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine.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:49738-050-34236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/13/2006
    Labeler - Kmart Corporation (008965873)
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