Label: IODINE TOPICAL SOLUTION - povidone-iodine solution 

  • NDC Code(s): 41250-677-94
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 12/09

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  • ACTIVE INGREDIENT

    Povidone Iodine,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

    NDC 41250-677-94

    meijer

    Iodine
    Topical
    Solution

    povidone iodine USP, 10%

    TOPICAL ANTISEPTIC
    HELPS PREVENT INFECTION IN MINOR CUTS, SCRAPES AND BURNS
    WATER SOLUABLE

    MEIJER PHARMACIST RECOMMENDED

    COMPARE TO BETADINE®
    active ingredient*

    8 FL OZ (236 mL)

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544

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

    label



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  • INGREDIENTS AND APPEARANCE
    IODINE TOPICAL SOLUTION 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41250-677
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    povidone-iodine (povidone-iodine) povidone-iodine .10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    citric acid monohydrate  
    glycerin  
    sodium hydroxide  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-677-94 236 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/02/2004
    Labeler - Meijer Distribution Inc (006959555)
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