Label: FOAMING ANTISEPTIC solution

  • NDC Code(s): 64542-683-41
  • Packager: State Industrial Products
  • 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: To decrease bacteria on skin, apply a small amount covering hands with product for 30 seconds. Add water, lather and rinse. This product should be used once or twice daily as part of the daily cleaning routine. Children under 6 years of age should be supervised when using this product.

  • INDICATIONS & USAGE

    Uses: Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • ACTIVE INGREDIENT

    Active Ingredient: Benzalkonium Chloride 0.13% 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.

  • PURPOSE

    Purpose Antibacterial Agent

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

  • WARNINGS

    Warnings: For external use only. Contact with eyes should be avoided. In case of contact, immediately flush with water. Stop use and ask a doctor if irritation or rash appears and last more that 72 hours.

  • PRINCIPAL DISPLAY PANEL

    State LabelPrincipal Label

  • INGREDIENTS AND APPEARANCE
    FOAMING ANTISEPTIC 
    foaming antiseptic solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64542-683
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64542-683-411000 mL in 1 BAG; Type 0: Not a Combination Product06/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2016
    Labeler - State Industrial Products (004520987)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(64542-683)
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