Label: PREVENT- chloroxylenol soap

  • 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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  • Prevent

    ​Active Ingredient

    Chloroxylenol 0.375%

  • Prevent

    Uses

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

    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.
  • Prevent

    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
  • Prevent

    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.

  • Prevent

    Purpose

    Antibacterial

  • Prevent

    Winning Hands Antibacterial

    KEEP OUT OF REACH OF CHILDREN

  • Prevent

    UltraChem 141 UltraChem 141

  • INGREDIENTS AND APPEARANCE
    PREVENT 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66077-708
    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
    BENZYL BENZOATE (UNII: N863NB338G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
    ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
    ETHYLENE OXIDE (UNII: JJH7GNN18P)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    DIOXANE (UNII: J8A3S10O7S)  
    DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM FERROCYANIDE (UNII: 5HT6X21AID)  
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CHLOROACETIC ACID (UNII: 5GD84Y125G)  
    DIMETHYL BENZYL CARBINYL BUTYRATE (UNII: 3Q0C60547R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66077-708-55208 mL in 1 DRUM; 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 - Ultra-Chem Inc. (181772757)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corpo, Ltd.005050158manufacture(66077-708) , label(66077-708) , pack(66077-708)
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