Label: ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 11344-713-04, 11344-713-44, 11344-713-50, 11344-713-51, view more
    11344-713-57, 11344-713-68, 11344-713-90
  • Packager: Vi-Jon, LLC
  • 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 September 12, 2022

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  • 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, isopropylideneglycerol, sodium chloride, alcohol denat., fragrance, phenoxyethanol, citric acid, methylisothiazolinone, trisodium ethylenediamine disuccinate, yellow 5, blue 1

  • adverse reactions section

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Dawn Ultra Antibacterial Hand Soap Apple Blossom Scent

    Do not add bleach.  Not for use in dishwashers.

    Contains surfactants.  Phosphate-free formula.

    Manufactured by: Vi-Jon, Inc. St. Louism MO 63114

    Questions or comments?  1-888-593-0593

    Made in the USA with US and foreign components

  • principal display panel

    mountain

    falls

    *Compare to Dawn

    tough on grease

    ultra concentrated cleaning power

    dish soap

    antibacterial hand soap

    crisp apple scent

    90 FL OZ (2.66 L)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-713
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 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 LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-713-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    2NDC:11344-713-50710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    3NDC:11344-713-041040 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    4NDC:11344-713-571183 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    5NDC:11344-713-681650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    6NDC:11344-713-511770 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2017
    7NDC:11344-713-902662 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, LLC (790752542)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11344-713)
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