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
  • 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 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 not finalpart333E03/30/2017
    Labeler - RJ Schinner (023432909)
    Registrant - Kutol Products, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products, Inc.004236139manufacture(71303-213)
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