Label: ANTIBACTERIAL- benzalkonium chloride 0.13% liquid

  • Category: HUMAN OTC DRUG LABEL

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 July 10, 2020

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  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Use help eliminate bacteria on hands

  • Warnings 

    For external use only

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • When using this product

    Avoid contact with eyes.In case of contact, flush and rinse with water.

  • Keep out of reach of children

    Except under adult supervision. 

    If swallowed get medical help or contact posion control right away.

  • Directions

    Wash hands and rinse

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Coamide Methyl MEA, Fragrance, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, DMDM Hydantoin ,Cl 14700, Cl 15510.

  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PRINCIPAL DISPLAY PANEL

    lemon

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    benzalkonium chloride 0.13% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72308-013-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/10/2020
    Labeler - Flex Beauty Labs (080858917)
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