Label: INDIVIDUAL ANTIBACTERIALLOTION SKIN CLEANSER- 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 March 2, 2022

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  • Active ingredient

    Chloroxylenol 0.375% w/w

  • Uses

    Antibacterial skin cleanser

    Effective in destroying harful bacteria to prevent antibacterial cleansing

  • Warnings

    For external use only.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Read entire label before using this product.

    Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

    Scrub thoroughly for 20 seconds and rinse with clean water.

  • Inactive Ingredients

    Cocamidopropyl Betaine, Coco MIPA, D&C Green 5, Ethylene Glycol Phenyl Ether, Fragrance, FD&C Yellow 5, Glycerin, Glycol Distearate, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Propylene Glycol, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Water.

  • Purpose

    Antibacterial

  • Keep out of reach of children

    Keep out of the reach of children

  • Label

    Individual Antibacterial Lotion Skin Cleanser

  • INGREDIENTS AND APPEARANCE
    INDIVIDUAL ANTIBACTERIALLOTION SKIN CLEANSER 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79258-141
    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
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
    DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    CHLOROACETIC ACID (UNII: 5GD84Y125G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM FERROCYANIDE (UNII: 5HT6X21AID)  
    DIOXANE (UNII: J8A3S10O7S)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    IONONE (UNII: QP734LIN1K)  
    ETHYLENE OXIDE (UNII: JJH7GNN18P)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
    MYRCENE (UNII: 3M39CZS25B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79258-141-043785 mL in 1 JUG; Type 0: Not a Combination Product03/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/02/2022
    Labeler - Brady Industries Inc. (034932657)
    Registrant - Betco Corporation (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation005050158manufacture(79258-141) , label(79258-141) , analysis(79258-141) , pack(79258-141)
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