Label: FOAMING ANTIBACTERIAL HAND WASH- 0.13% benzalkonium chloride soap

  • NDC Code(s): 71303-213-31, 71303-213-41
  • Packager: RJ Schinner
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Dosage and Administration

    Directions Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

  • Inactive Ingredients

    Inactive Ingredients Water, Cocamidopopyl Betaine, Cocamidoprpyl PG-Dimonium Chloride Phosphate, PEG-6 Cocamide, Laurtrimonium Chloride, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Yellow 5, Red 33.

  • Indications and Uses

    Uses For handwashing to decrease bacteria on the skin.

  • Keep Out Of Reach Of Children

    Keep out of reach of children. If swallowed, contact a physician or poison control center.

  • Purpose Section

    Purpose Antibacterial Agent

  • Active Ingredient Section

    Active Ingredient Benzalkonium Chloride 0.13% w/w

  • Warnings Section

    Warnings

    For external use only

    Avoid contact with eyes. If contact occurs, flush with water.

    Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours

  • Primary Display Label

    Primary Display Label

  • INGREDIENTS AND APPEARANCE
    FOAMING ANTIBACTERIAL HAND WASH 
    0.13% benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71303-213
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    HC YELLOW NO. 5 (UNII: I844A312T7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71303-213-311000 mL in 1 BAG; Type 0: Not a Combination Product03/30/2017
    2NDC:71303-213-411000 mL in 1 BAG; Type 0: Not a Combination Product03/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/30/2017
    Labeler - RJ Schinner (023432909)
    Registrant - Kutol Products, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products, Inc.004236139manufacture(71303-213)
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