Label: BZK SANITIZING HAND WIPES- benzalkonium chloride cloth

  • 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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  • Directions for Use:

    Wipe liberally over the hands, rub into skin until dry. Recommended for single use.

  • Active Ingredient:

    Benzalkonium Chloride 0.13%

    Purpose:

    Antiseptic/ hand and skin sanitizer

  • Uses:

    Sanitizing hand wipes help decrease bacteria on the skin. Recommended for single use

  • Inactive Ingredients:

    Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, L a u r e t h - 4 , P o l y h e x a n i d e , Phenoxyethanol, Trielhoxysilylpropyl
    Steardimonium Chloride.

  • 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.

  • Questions?

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

  • Package Labeling:

    Bottle6

  • INGREDIENTS AND APPEARANCE
    BZK SANITIZING HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81529-003
    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
    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:81529-003-0180 in 1 CANISTER02/03/2020
    16.25 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/03/2020
    Labeler - Premium PPE, LLC (117835683)
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