Label: UNITEX ANTIBACTERIAL LOTIONHANDSOAP- chloroxylenol liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 28, 2024

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  • 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 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

    141-01

  • INGREDIENTS AND APPEARANCE
    UNITEX ANTIBACTERIAL LOTIONHANDSOAP 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84955-841
    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
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
    4-ACETOXY-3-PENTYLTETRAHYDROPYRAN (UNII: 30E3255185)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)  
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    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)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)  
    DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
    HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATE (UNII: S3ASM14UAS)  
    VERDYL ACETATE (UNII: 5232EN3X2F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84955-841-043780 mL in 1 JUG; Type 0: Not a Combination Product11/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/12/2012
    Labeler - Jon-Don LLC (091773820)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.005050158manufacture(84955-841) , label(84955-841)