Label: ANTIBACTERIAL HAND CLEANSER- benzalkonium chloride soap

  • NDC Code(s): 66608-215-09, 66608-215-65, 66608-215-78
  • Packager: Kimball Midwest
  • 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 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 Section

    Inactive Ingredients Water, Cetrimonium Chloride, Lauramine Oxide, Sorbitol, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Sodium Lauraminodipropionate, Citric Acid, Fragrance, Disodium EDTA, Methyllisothiazolinone, Methylchloroisothiazolinone, Yellow 5, Red 33

  • Indications and Usage Section

    Uses Handwash to help decrease bacteria on skin.

  • Keep Out Of Reach Of Children Section

    Keep Out Of Reach Of Children If swallowed, get medical help or contact a Poison Control Center right away.

  • Purpose Section

    Purpose Antibacterial Handwashing

  • Active Ingredient Section

    Active Ingredient Benzalkonium Chloride 0.13% w/w

  • Warnings Section

    Warnings

    For external use only.

    Do not use in eyes. In case of contact, immediately flush with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • Principal Display Label

    Pricipal Label Display

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND CLEANSER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66608-215
    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
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ACID RED 35 (UNII: 02BXM5Q7GE)  
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SORBITOL (UNII: 506T60A25R)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM LAURIMINODIPROPIONATE (UNII: 7G447D0DH9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66608-215-781000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/2017
    2NDC:66608-215-65800 mL in 1 BAG; Type 0: Not a Combination Product06/28/2017
    3NDC:66608-215-093785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/28/2017
    Labeler - Kimball Midwest (017906231)
    Registrant - Kutol Products, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products, Inc.004236139manufacture(66608-215)
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