Label: ANTIBACTERIAL HAND- antiseptic hand soap soap

  • NDC Code(s): 61307-060-09
  • Packager: US Chemical Corporation
  • 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 August 24, 2023

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  • DOSAGE & ADMINISTRATION

    Directions Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse. Children under 6 years of age should be supervised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Tall Oil Acide, Potassium Hydroxide, Coconut Acid, Phenoxyethanol, Cocamide DIPA, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance, Sodium Sulfate, Iodopropynl, Butylcarbamate, Yellow 5, Red 33.

  • INDICATIONS & USAGE

    Uses Handwash to help decrease bacteria on the skin.

  • ACTIVE INGREDIENT

    Active Ingredient Chloroxylenol 0.3% w/w

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    Purpose Antibacterial Agent

  • WARNINGS

    Warnings For external use only. Avoid contact with eyes. In case of contact, flush with plenty of water. Stop use, and ask a doctor if irritation or rash appears and persists.

  • PRINCIPAL DISPLAY PANEL

    Principal Label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    antiseptic hand soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61307-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TALL OIL ACID (UNII: H9HR63474M)  
    COCONUT ACID (UNII: 40U37V505D)  
    ACID RED 35 (UNII: 02BXM5Q7GE)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61307-060-093785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/13/2013
    Labeler - US Chemical Corporation (031457842)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(61307-060)
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