Label: IODINE TOPICAL SOLUTION- 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 December 23, 2009

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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, nonoxynol-8, purified water, sodium hydroxide
  • QUESTIONS


  • 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



  • INGREDIENTS AND APPEARANCE
    IODINE TOPICAL SOLUTION 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-677
    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:41250-677-94236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/02/2004
    Labeler - Meijer Distribution Inc (006959555)
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