Label: GRX DYNE SCRUB - 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 3, 2012

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

  • Active Ingredient

    Active Ingredient:                      Purpose

    Povidone-Iodine, 7.5%              Antiseptic

    (Equal to 0.75% available Iodine) Close
  • uses

    Disinfectant hand wash and skin cleanser.

    Significantly reduces bacteria on the skin.

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  • Directions

    Wet skin and apply a sufficient amount for lather to

    cover all surfaces.

    Wash vigorously for at least 15 seconds.

    Rinse and dry thoroughly.

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  • DOSAGE & ADMINISTRATION

    Wash vigorously for at least 15 seconds. Close
  • Warnings

    For External Use Only

    Do not use this product:

    If you are sensitive to iodine or other products ingredients.

    In the eyes.

    Over large areas of the body.

    Longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    Deep puncture wounds: serious burns: or animal bites.

    Stop using this product and ask a doctor if;

    Redness, irritation, swelling, or pain continues or increases, or infection occurs.


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  • Inactive Ingredient

    Citric acid, glycerin, Nonoxynol 10, purified water, sodium hydroxide Close
  • STORAGE AND HANDLING

    Store at 25'C (77'F); excursions permitted between

    15'-30'C (59'-86'F)

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • PRINCIPAL DISPLAY PANEL

    Label of BottleEnter section text here

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  • INGREDIENTS AND APPEARANCE
    GRX DYNE SCRUB 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-268
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 7500 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54162-268-04 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 07/03/2012
    Labeler - Geritrex Corp. (112796248)
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