Label: POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC - povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/10

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  • ACTIVE INGREDIENT

    Active ingredeint
    Povidone-iodine, 10%(equivalent to 1% available iodine)

    Purpose
    Antiseptic
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  • INDICATIONS & USAGE

    Uses first aid to help prevent the risk of infection in minor cuts, scrapes and  burns
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  • WARNINGS

    Warnings
    For external use only

    Ask A doctor before use if you have
    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product
    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water
    • do not apply over large areas of the body
    • do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if
    • condition persists or gets worse

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
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  • DOSAGE & ADMINISTRATION

    Directions
    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily.
    • may be covered with a sterile bandage.  If bandaged, let dry first.
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  • STORAGE AND HANDLING

    Other information
    store at room temperature
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  • INACTIVE INGREDIENT

    Inactive ingredients citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide
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  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by the Purdue Frederick Company, distributor of Betadine
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  • PRINCIPAL DISPLAY PANEL

    NDC 0896-0050-34  
    Povidone-
    Iodine
    Solution, 10%
    Soluciond de povidona yodada. 10%
    First Aid Antiseptic
    Antisepito para primeros auxilios
    Kills Germs in Monor, Burns, Cuts and Scrapes
    Compare to Active Ingredient of Betadine
    8 FL OZ (237 mL)
    image of principal display panel

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  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0869-0050
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE 10 kg  in 100 L
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    NONOXYNOL-9  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0869-0050-34 .2 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 05/07/2009
    Labeler - Vi Jon (790752542)
    Registrant - Vi Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi Jon 790752542 manufacture
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