Label: SKIN CLEANSER- chloroxylenol soap

  • NDC Code(s): 72528-141-04
  • Packager: West Coast Paper Company
  • 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 25, 2022

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  • Active Ingredient

    Chloroxylenol 0.375%

  • 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

    If contact occurs, risne thoroghly with water

    Discontinue use if irritation or redness develops

    If irritation persists for more than 72 hours, consult a physician

    KEEP OUT OF REACH OF CHILDREN

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

  • Directions


    Read the entire label before using this product

    Place enough product on your palm to thoroughly cover your hands

    Rinse with clean water

  • Inactive Ingredients


    Water, Cocamidopropyl Betaine, Sodium Lauryl Ether Sulfate, Ethylene Glycol Phenyl Ether, Cocamide
    MIPA, Ethanol, Gycerin, Propylene Glycol, Glycol Distearate, Fragrance, Sodium Chloride,
    Methylchloroisothiazolinone, Lauramide MIPA, Sodium Hydroxide, Disodium Cocamido MIPA-Sulfosuccinate,
    Methylisothiazolinone, D&C Green #5, FD&C Yellow #5.

  • Purpose

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    SKIN CLEANSER 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72528-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    LAURAMIDE (UNII: 3BD22052MO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    COCAMIDE (UNII: 3YXD33R71G)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72528-141-043785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2022
    Labeler - West Coast Paper Company (008958118)
    Registrant - Betco Corporation (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation024492831manufacture(72528-141) , label(72528-141)
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