Label: CRYSTAL CLEAN ANTIBACTERIAL HANDSOAP- chloroxylenol liquid

  • NDC Code(s): 68041-001-16, 68041-001-50
  • Packager: Chemcor Chemical Corporation
  • 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 January 2, 2023

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  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.375%

  • Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses • Antibacterial hand cleaner. Use in daycare, hospitals, nursing homes, physician offices, dental offices and clinics.

  • Warnings

    •For external use only. • Avoid contact with eyes. • Discontinue if irritation or redness develops.

    When using this product • keep out of eyes. In case of contact with eyes, flush thoroughly with water. • avoid contact with broken skin • do not inhale or ingest.

    Stop use and ask a doctor if • irritation or redness develops • 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

  • DOSAGE & ADMINISTRATION

    Directions • Ready to use without dilution. • Place enough product on hands to cover all surfaces. Scrub thoroughly all over surface of both hands. • Rinse with clean water and dry.

  • STORAGE AND HANDLING

    Other information • Do not store above 105°F • Refer to product Safety Data Sheet (SDS) for additional information.

  • Inactive ingredients

    Water, sodium lauryl sulfate, cocamidopropyl betaine, sodium lauryl ether sulfate, sodium chloride, ethylenedinitrilo(tetraacetic) acid disodium salt dihydrate, 4-chloro-3,5-dimethylphenol, fragrance, ethoxylated C10-14 alcohols, methylisothiazolinone, red dye, orange dye

  • SPL UNCLASSIFIED SECTION

    TOUGH on GERMS and BACTERIA

    Moisturizing | Pleasant Fragrance | Gentle on Hands

    May be harmful if swallowed. May cause irritation to eyes.

    Chemcor Chemical Corporation 13770 Benson Ave., Chino, CA 91710 USA

    1-877-CHEMCOR - www.ChemcorChemical.com

    MADE IN USA

    24-Hour Chemical Emergency

    Response Number: 1-800-535-5053

  • Packaging

    Crystal-1

    Crystal-2

  • INGREDIENTS AND APPEARANCE
    CRYSTAL CLEAN ANTIBACTERIAL HANDSOAP 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68041-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.00375 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    C10-16 ALKETH-1 (UNII: 3Y76363WPB)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ACID ORANGE 20 (UNII: W9Q9OB858O)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68041-001-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    2NDC:68041-001-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/12/2020
    Labeler - Chemcor Chemical Corporation (018129978)
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