Label: ECOLAB - 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 July 1, 2011

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

  • Active ingredient

    Povidone Iodine, 7.5%

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  • Purposes

    Surgical hand scrub

    Antiseptic handwash

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  • Uses

    • surgical hand scrub: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
    • antiseptic hand wash: for handwashing to help reduce bacteria on the skin
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  • Warnings

    For external use only

    Do not use

    • in eyes

    When using this product

    • if in eyes, rinse promptly and thoroughly with water
    • discontinue use if irritation and redness develop

    Stop use and ask a doctor if

    • skin irritation and redness occurs for more than 72 hours.

    Keep out of reach of children.  If swallowed, get medical help or contact Poison Control Center right away.

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  • Directions

    Surgical scrub

    • remove jewelry
    • clean nails with an orangewood stick
    • wet hands and forearms with water and apply 5 mL ofthe product
    • wash/scrub hands and forearms for 5 minutes paying particular attention to nails, cuticles, and interdigital spaces
    • rinse thoroughly with water
    • wet hands and forearms with water and apply 5 ml ofthe product
    • wash hands and forearms for 5 minutes
    • rinse thoroughly with water
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    Antiseptic handwash

    • wet hands and forearms
    • dispense a palmful of product to hands
    • scrub hands and forearms for 20 seconds
    • rinse thoroughly and dry
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  • Other information

    • for additional information, see Material Safety Data Sheet
    • for emergency medical information in USA and Canada, call 1-800-328-0026
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  • Inactive ingredients

    water (aqua), ammonium nonoxynol-4 sulfate, ethanol, sodium citrate

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  • Questions?

    call1.866.781.8787, 24 hours a day, 7 days a week

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  • Principal Display Panel / Representative Label

    ECOLAB

    NDC 47593-483-36

    IODINE FOAM SURGICAL SCRUB

    Active Ingredient: Povidone Iodine 7.5%

    6084332

    Net Contents: 800 mL (27 US fl oz)

    Representative Label

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  • INGREDIENTS AND APPEARANCE
    ECOLAB 
    povidone iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-483
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 7.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47593-483-36 800 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 06/24/2011
    Labeler - Ecolab Inc. (006154611)
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