Label: DYNAREX GREEN- chloroxylenol liquid

  • 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 December 13, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient                         Purpose

    Chloroxylenol 0.15%                   Antiseptic

  • WARNINGS

    • For external use only
    • When using this product avoid contact with eyes. In case of contact, flush with water.
  • PURPOSE

    An antiseptic handwash.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if irritation and redness develop.

  • INDICATIONS & USAGE

    Cleaning and antiseptic cleansing of hands and skin.

  • DOSAGE & ADMINISTRATION

    • Wet hands and forearms. Apply 5 milliliters (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 1 minute. Rinse and repeat.
  • 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.

  • INACTIVE INGREDIENTS

    Inactive ingredients: Citric acid, Cocamidopropyl betaine, Cocmide DEA, D&C Red #33, Disodium EDTA, Frgarance, Glycerin, Sodium chloride, Sodium Lauryl Sulphate, Sodium o-phenylphenate, water.

  • PRINCIPAL DISPLAY PANEL

    Dynarex Antibacterial Soap

    1438 Soap.jpg

    antibacterial soap

  • INGREDIENTS AND APPEARANCE
    DYNAREX GREEN 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM O-PHENYLPHENATE (UNII: KFV9K7N7UI)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-318-01221 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/13/2017
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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