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 April 15, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

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  • PURPOSE

    Antiseptic

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  • USE

    First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns
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  • 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.

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  • 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
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  • OTHER INFORMATION

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

    citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide Close
  • 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

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  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49738-050
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine .10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49738-050-34 236 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/13/2006
    Labeler - Kmart Corporation (008965873)
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