Label: ANTIBACTERIAL SKIN CLEANSER- chloroxylenol soap

  • NDC Code(s): 65601-708-04, 65601-708-10, 65601-708-19, 65601-708-29, view more
    65601-708-41, 65601-708-55, 65601-708-88
  • Packager: Betco Corporation, Ltd.
  • 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 September 11, 2020

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

View All Sections
  • Active Ingredient

    Chloroxylenol 0.375%

  • 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 Laureth lSulfate, Cocamidopropyl betadine, Phenoxyethanol, Coco MIPA, Glycol Stearate, DMDM Hydantoin, Propylene Glycol, Sodium Chloride, Fragrance, Glycerin, Ethanol,  D&C Green #5, FD&C Yellow #5.

  • Purpose

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    Winning Hands Antibacterial

    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

    291910880455

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL SKIN CLEANSER 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-708
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALCOHOL (UNII: 3K9958V90M)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    DIMETHYL BENZYL CARBINYL BUTYRATE (UNII: 3Q0C60547R)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    SODIUM FERROCYANIDE (UNII: 5HT6X21AID)  
    ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
    CHLOROACETIC ACID (UNII: 5GD84Y125G)  
    IONONE (UNII: QP734LIN1K)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    MYRCENE (UNII: 3M39CZS25B)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    ETHYLENE OXIDE (UNII: JJH7GNN18P)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    DIOXANE (UNII: J8A3S10O7S)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-708-043780 mL in 1 JUG; Type 0: Not a Combination Product02/01/2016
    2NDC:65601-708-19900 mL in 1 BAG; Type 0: Not a Combination Product02/01/2016
    3NDC:65601-708-412000 mL in 1 BAG; Type 0: Not a Combination Product02/01/201607/15/2020
    4NDC:65601-708-55207900 mL in 1 DRUM; Type 0: Not a Combination Product02/01/2016
    5NDC:65601-708-101100 mL in 1 BAG; Type 0: Not a Combination Product02/01/2016
    6NDC:65601-708-291000 mL in 1 BAG; Type 0: Not a Combination Product11/12/2012
    7NDC:65601-708-88500 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 not finalpart333A11/12/2012
    Labeler - Betco Corporation, Ltd. (024492831)
    Registrant - Betco corporation, Ltd. (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.024492831manufacture(65601-708) , pack(65601-708) , label(65601-708)
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!