Label: ANTIBACTERIAL HANDSOAP- chloroxylenol liquid

  • NDC Code(s): 68041-504-01
  • 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

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

  • Drug Facts

  • Active Ingredient

    Chloroxylenol 0.375%

  • Purpose

    Antimicrobial

  • Uses

    • Handwash to help decrease bacteria on skin

    • Recommended for repeated use

  • Warnings

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands

    • Apply product and thoroughly cover all surfaces of both hands with lather

    • Rinse both hands well

    • Dry hands completely

  • 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

    moisturizes

    hard on germs

    tough on surface bacteria

    MAY BE HARMFUL IF SWALLOWED.

    MAY CAUSE IRRITATION TO EYES.

    SEE BACK PANEL FOR ADDITIONAL PRECAUTIONS AND FIRST AID.

    institutional & commercial antibacterial hand cleanser

    DESCRIPTION

    AN EFFECTIVE ANTIBACTERIAL LOTION HAND AND SKIN CLEANSER WHICH CONTAINS CHLOROXYLENOL, AN OUTSTANDING GERM FIGHTING INGREDIENT. FORMULATED TO BE TOUGH ON BACTERIA AND GERMS. REGULAR USE OF THIS ANTIBACTERIAL HAND SOAP HELPS DECREASE BACTERIA LEVELS ON THE SKIN AND HELPS REDUCE RISK OF INFECTIONS. PRODUCES RICH MOISTURIZING LATHER TO PROMOTE COMPLETE GENTLE CLEANSING. LEAVES THE SKIN CLEAN, SOFT AND REFRESHED. IDEAL FOR DISPENSING IN LIQUID SOAP PUMP DISPENSERS.

    Before discarding container, rinse with water.

    For institutional and commercial use.

    MFG By: Chemcor Chemical Corporation

    13770 Benson Avenue, Chino, CA 91710

    1877-CHEMCOR / www.ChemcorChemical.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HANDSOAP 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68041-504
    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:68041-504-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/12/2020
    Labeler - Chemcor Chemical Corporation (018129978)