Label: HI-TECH- chloroxylenol soap

  • NDC Code(s): 57424-708-04
  • Packager: Economical Janitorial Supplies
  • 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 July 29, 2020

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  • Hi-Tech

    ​Active Ingredient

    Chloroxylenol 0.375%

  • Hi-Tech

    Uses

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

    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.
  • Hi-Tech

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 1-2 pumps of product onto wet palm.
    • Lather and rinse hands with clean water
  • Hi-Tech

    Inactive Ingredients

    ​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

  • Hi-Tech

    Purpose

    Antibacterial

  • Hi-Tech

    Winning Hands Antibacterial

    KEEP OUT OF REACH OF CHILDREN

  • Economical Hi Tech Antiseptic Hand

    14104-00 economical Hi Tech Antiseptic Hand14104-00 Economical Hi Tech Antiseptic Hand

  • INGREDIENTS AND APPEARANCE
    HI-TECH 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57424-708
    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
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    DIOXANE (UNII: J8A3S10O7S)  
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ETHYLENE OXIDE (UNII: JJH7GNN18P)  
    ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CHLOROACETIC ACID (UNII: 5GD84Y125G)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    MYRCENE (UNII: 3M39CZS25B)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
    DIMETHYL BENZYL CARBINYL BUTYRATE (UNII: 3Q0C60547R)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SODIUM FERROCYANIDE (UNII: 5HT6X21AID)  
    ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
    DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57424-708-043780 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 not finalpart333A11/12/2012
    Labeler - Economical Janitorial Supplies (065026163)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corpo, Ltd.005050158pack(57424-708) , label(57424-708) , manufacture(57424-708)
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