Label: CHLOROXYLENOL liquid

  • NDC Code(s): 55910-984-44, 55910-984-57
  • Packager: Old East Main Co
  • 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 9, 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 Control Center right away.

  • Directions

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

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

  • SPL UNCLASSIFIED SECTION

    Do not add bleach.

    Not for use in dishwashers.

    Contains Surfactants  Phosphate Free

    **When compared to non-concentrated formulas

    *This product is not manufactured or distributed by Procter & Gamb;le, distributor of Dawn Ultra Antibacterial Hand Soap Orange Scent

  • principal display panel

    ULTRA CONCENTRATED 3X CLEANING POWER

    trueliving

    ULTRA

    Antibacterial

    Hand Soap

    Dishwashing Liquid

    TOUGH ON GREASE

    Compare to Dawn Ultra Antibacterial Hand Soap Orange Scent

    CITRUS ORANGE SCENT

    18 FL OZ (532 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CHLOROXYLENOL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-984
    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 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)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-984-44532 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2020
    2NDC:55910-984-571183 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    Labeler - Old East Main Co (068331990)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc088520668manufacture(55910-984)