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

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  • Active Ingredient

    Active Ingredient:                      Purpose

    Povidone-Iodine, 7.5%              Antiseptic

    (Equal to 0.75% available Iodine)
  • uses

    Disinfectant hand wash and skin cleanser.

    Significantly reduces bacteria on the skin.

  • 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.

  • DOSAGE & ADMINISTRATION

    Wash vigorously for at least 15 seconds.
  • 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.


  • Inactive Ingredient

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

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

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    Label of BottleEnter section text here

  • INGREDIENTS AND APPEARANCE
    GRX DYNE SCRUB 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-268
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE7500 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-268-04118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/03/2012
    Labeler - Geritrex Corp. (112796248)
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