Label: BZK ALCOHOL FREE HAND SANITIZER- benzalkonium chloride spray

  • 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 25, 2021

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  • Drug Facts

  • Active Ingredient:

    Benzalkonium Chloride 0.13%

    Purpose:

    Hand & Skin Sanitizer

  • Uses:

    BZK™ Alcohol Free Hand Sanitizer provides revolutionary protection in an alcohol-free formula. The scientifically-proven solution kills harmful germs, bacteria, and microbes, and gently soothes and softens skin with aloe vera. Recommended for repeated use.

  • Warnings:

    Do not freeze

    + For external use only 

    Do not use

    + in ears, eyes or mouth

    When using this product,

    +avoid contact with the eyes

    + In case of contact, flush eyes with water

    Stop use and ask a doctor if

    +redness or irritation develops and persists for more than 72 hours

    Keep out of reach of children

    +Children should be supervised when using this product.

  • Directions:

    Apply liberally to the palms of the hands or areas of damaged skin. Rub into skin until dry. Recommended for repeated use.

  • Other Information:

    Store in a cool dry place below 104°F(40°C).

  • Inactive Ingredients:

    Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.

  • Questions?

    1-800-920-7650 Mon-Fri 10AM-4PM (EST)

  • Package Labeling:

    59 mL

  • INGREDIENTS AND APPEARANCE
    BZK ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81529-001
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81529-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product02/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/03/2021
    Labeler - Premium PPE, LLC (117835683)
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