Label: ANTIBACTERIAL HAND CLEANSER- benzalkonium chloride soap

  • NDC Code(s): 50865-215-09, 50865-215-12, 50865-215-19, 50865-215-65
  • Packager: Kutol Products Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 28, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.13% w/w

  • PURPOSE

    Purpose

    Antibacterial Handwashing

  • 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.

  • INDICATIONS & USAGE

    Uses Handwash to decrease bacteria on the skin.

  • 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.
  • WARNINGS

    Warnings

    For external use only.

    Do not usein the eyes. In case of contact, immediately flush with water.

    Stop use and ask a doctor if redness and irritation appears and lasts.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, cetrimonium chloride, lauramine oxide, sorbitol, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, sodium lauraminodipropionate, citric acid, fragrance, disodium EDTA, methyisothiazolinone, methylchloroisothiazolinone, yellow 5, red 33

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND CLEANSER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-215
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SORBITOL (UNII: 506T60A25R)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM LAURIMINODIPROPIONATE (UNII: 7G447D0DH9)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50865-215-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2017
    2NDC:50865-215-121200 mL in 1 BAG; Type 0: Not a Combination Product08/17/2017
    3NDC:50865-215-19237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/17/2017
    4NDC:50865-215-65800 mL in 1 BAG; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/17/2017
    Labeler - Kutol Products Company (004236139)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(50865-215)
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