Label: ANTIBACTERIAL LOTIONS SKIN CLEANSER- chloroxylenol soap

  • NDC Code(s): 65601-841-04, 65601-841-10, 65601-841-19, 65601-841-29, view more
    65601-841-55, 65601-841-88
  • Packager: Betco Corporation, Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 18, 2024

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

View All Sections
  • Active Ingredient

    Chloroxylenol 0.40%

  • Uses

    • ​​Antibacterial hand cleaner.
    • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics
  • Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is 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.
    • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
    • Rinse with clean water.
  • Inactive Ingredients

    Water, Sodium Chloride, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Ethylene Glycol Phenyl Ether, Glycerin, Fragrance, Propylene Glycol, Sodium Hydroxide, Cocamidopropylamine Oxide, Sodium Benzoate, Glycol Distearate, Lauramide MIPA, Disodium Cocamido MIPA Sulfosuccinate, D&C Green 5, FD&C Yellow 5.

  • Purpose

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    Antibacterial Lotion Skin Cleanser

    KEEP OUT OF REACH OF CHILDREN

  • SPL UNCLASSIFIED SECTION

    ©2017 Betco Corporation

    400 Van Camp Road Bowling Green, Ohio 43402

    Made In U.S.A. All Rights Reserved.

    888-GO BETCO (888-462-3826) | Betco.com

  • PRINCIPAL DISPLAY PANEL

    E955291904

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL LOTIONS SKIN CLEANSER 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-841
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)  
    VERDYL ACETATE (UNII: 5232EN3X2F)  
    1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)  
    3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
    4-ACETOXY-3-PENTYLTETRAHYDROPYRAN (UNII: 30E3255185)  
    DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATE (UNII: S3ASM14UAS)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    ETHYLENE OXIDE (UNII: JJH7GNN18P)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-841-043780 mL in 1 JUG; Type 0: Not a Combination Product02/01/2016
    2NDC:65601-841-19900 mL in 1 BAG; Type 0: Not a Combination Product02/01/2016
    3NDC:65601-841-55207900 mL in 1 DRUM; Type 0: Not a Combination Product02/01/2016
    4NDC:65601-841-101100 mL in 1 BAG; Type 0: Not a Combination Product02/01/2016
    5NDC:65601-841-291000 mL in 1 BAG; Type 0: Not a Combination Product11/12/2012
    6NDC:65601-841-88500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/12/2012
    Labeler - Betco Corporation, Ltd. (005050158)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.005050158label(65601-841) , manufacture(65601-841)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!