GRX DYNE SCRUB (POVIDONE-IODINE) SOLUTION [GERITREX CORP.]

GRX DYNE SCRUB (POVIDONE-IODINE) SOLUTION [GERITREX CORP.]
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NDC 54162-268-04
Set ID 4779974e-c149-489d-9cce-a0e9e0e921c9
Category HUMAN OTC DRUG LABEL
Packager Geritrex Corp.
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333A
  • 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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