Label: ANTIBACTERIAL- benzalkonium chloride liquid

  • 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 June 22, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Use help eliminate bacteria on hands

  • Warnings For external use only

    Causes serious eye damage. Toxic to aquatic life.Avoid release to the environment.

    Dispose of contents/container in accordance with national regulations.

  • 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.

    Remove contact lenses, if present, and easy to do. Continue rinsing.

  • Keep out of reach of children

    Except under adult supervision. DO NOT EAT DRINK.

    Keep away from food,drink and animal feeding stuffs,

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

  • Directions

    apply onto wet hands.

    Lather and rinse thoeoughly.

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4,Benzyl Alcohol,Limonene.

  • PRINCIPAL DISPLAY PANEL

    GRAP

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78242-005
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78242-005-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2020
    Labeler - DIAMO KOZMETIK SANAYI IC VE DIS TICARET LIMITED SIRKETI (504571389)
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