Label: ANTIBACTERIAL HAND CLEANSER- benzalkonium chloride soap

  • 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 January 16, 2019

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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 use in 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 not finalpart333E08/17/2017
    Labeler - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(50865-215)
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