Label: GRX DYNE- 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 May 16, 2012

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  • Drug Facts

    Active Ingredient:                      Purpose

    Povidone Iodine USP, 10% w/v  Antiseptic

    (equivalent to 1% titratable Iodine)

  • Uses

    First aid antiseptic to help the risk of infection in

    minor cuts, scrapes or burns

  • Directions

    Clean the affected area

    Apply a small amount of this product to the area 1-3 times daily

    May be covered with a sterile bandaged

    If bandaged, let dry first

  • DOSAGE & ADMINISTRATION

    Apply a small amount of this product to the affected area 1-3 times daily
  • Warnings

    FOR EXTERNAL USE ONLY

    DO NOT

    Use in the eyes

    Use on individuals who are allergic of sensitive to iodine

    Apply over large areas of the body

    Discontinue use and ask a doctor

    If condition persist or gets worse

    For use longer than 1 week

    Ask a doctor in case of

    Deep or punctured wounds

    Animal bites

    Serious burns

  • Inactive Ingredient

    Citric acid, glycerin, Nonoxynol 10, purified water, sodium hydroxide

  • STORAGE AND HANDLING

    Store at room temperature: 15'-30'C (59'-86'F)

  • KEEP OUT OF REACH OF CHILDREN

    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 
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL  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:54162-269-16472 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/16/2012
    Labeler - Geritrex Corp. (112796248)
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