Label: CHLOROXYLENOL liquid

  • NDC Code(s): 11344-710-50, 11344-710-51, 11344-710-57
  • Packager: Vi-Jon, Inc
  • 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 August 27, 2020

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

  • Active ingredient

    Chloroxylenol 0.3%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only: hands only

  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water
  • Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
  • Keep out of reach of children.

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

  • Directions

    • wet hands
    • apply palmful to hands,
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    water, sodium C14-16 olefin sulfonate, lauramine oxide, sodium laureth sulfate, sodium lauryl sulfate, sodium xylenesulfonate, alcohol denat., phenoxyethanol, sodium chloride, citric acid, methylisothiazolinone, tetrasodium EDTA, fragrance, yellow 5, red 33

  • SPL UNCLASSIFIED SECTION

    Do not add bleach.  Not for use in dishwashers.

    ​Contains Surfactants. Phosphate Free

  • disclaimer

    This product is not manufactured or distributed by Procter & Gamble, distributor of Dawn Ultra Antibacteial Hand Soap Orange Scent

    710.000/710AA Rev 1

  • principal display panel

    mountain

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    *Compare

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    ultra

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    cleaning

    power

    dish soap

    atibacterial hand soap

    orange scent

    24 FL OZ (710 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CHLOROXYLENOL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.09 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-710-50710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    2NDC:11344-710-571183 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    3NDC:11344-710-511770 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/14/2017
    Labeler - Vi-Jon, Inc (150931459)
    Registrant - Vi-Jon, Inc (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc088520668manufacture(11344-710)