Label: ANTIBACTERIAL HAND LAVENDER SAGE- benzalkonium chloride liquid

  • NDC Code(s): 78784-003-01, 78784-003-02
  • Packager: GUANGZHOU SLUJ SPECIAL CHEMICAL CO., LTD
  • 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 February 23, 2023

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  • Drug Facts

  • Active Ingredient

    0.13% Benalkonium chloride 

    Purpose

    Antibacterial

  • Use

    helps eliminate bacteria on hands

  • Warnings

    For external use only

    When using this product 

    do not use in near the eyes. In case of contact, rinse eyes throughly with water.

    Keep out of the reach of children, 

    except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wash hands and rinse

  • Inactive Ingredients

    Water(Aqua),Sodium Laureth Sulfate,Cocamidopropyl Betaine, Sodium Chloride, Sodium Benzoate Phenoxyethanol,Polysorbate 20, Fragrance, Glycerin

  • Package Labeling:500ml

    Label

  • Package Labeling:3.78L

    Label2

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND LAVENDER SAGE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78784-003
    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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78784-003-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    2NDC:78784-003-023780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - GUANGZHOU SLUJ SPECIAL CHEMICAL CO., LTD (526847687)
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