Label: SCRUB-IN SURGICAL SCRUB BRUSH/SPONGE- povidone-iodine solution

  • NDC Code(s): 53329-920-09, 53329-920-33
  • Packager: Medline Industries, Inc.
  • 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 February 24, 2016

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  • Active ingredient

    Povidone-Iodine solution 9%

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  • Purpose

    Surgical Hand Scrub

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  • Uses

    For cleaning hands and forearms prior to surgery

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  • Warnings

    For external use only

    Do not use

    • in the eyes
    • if you are allergic to iodine or any of the other ingredients in this product

    Stop use and ask a doctor if

    • irritation and redness develop
    • symptoms last for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Wet hands and forearms with water
    • Clean under nails with nail cleaner
    • Scrub with the brush, paying close attention to the nails, cuticles, and interdigital spaces
    • Rinse thoroughly with running water
    • Repeat
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  • Other information

    • Avoid excessive heat above 40° C (104° F)
    • Protect from freezing
    • Latex free
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  • Inactive ingredients

    Ammonium Nonoxynol-4-Sulfate, Hydrogen Peroxide, Nonoxynol-9, Phosphoric Acid, Sodium Hydroxide, Water

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  • Questions?

    Call 1-800-MEDLINE

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  • PRINCIPAL DISPLAY PANEL

    NDC 53329-920-33

    Scrub-In

    REF DYND372453

    SURGICAL SCRUB BRUSH/SPONGE

    WITH NAIL CLEANER

    LATEX FREE

    • Povidone-Iodine 9% Antiseptic Solution
    • Approximate Volume 18 mL
    • For Single Use Only

    QTY 30

    label

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  • INGREDIENTS AND APPEARANCE
    SCRUB-IN SURGICAL SCRUB BRUSH/SPONGE 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-920
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-920-33 30 in 1 BOX
    1 NDC:53329-920-09 18 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/01/2012
    Labeler - Medline Industries, Inc. (025460908)
    Establishment
    Name Address ID/FEI Business Operations
    Medline Industries, Inc. 185862984 manufacture(53329-920) , analysis(53329-920)
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