Label: BZK TOWELETTE- benzalkonium chloride swab

  • 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 April 16, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride, 0.133% w/v

  • Purpose

    First Aid Antiseptic

  • Use

    Antiseptic Cleansing of face, hands and body without soap and water. Air dries in seconds.

  • Do Not Use

    In the eyes or apply over large areas of the body.

  • Stop Use

    If irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

  • Caution

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    Tear open packet, unfold and use as a washcloth.

  • Inactive Ingredients

    Sodium Bicarbonate, Water

  • Principal Display Panel - 1.4 mL Pouch Label

    Carton ImageCarton Image

  • INGREDIENTS AND APPEARANCE
    BZK TOWELETTE 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-7112(NDC:65517-0004)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.33 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-7112-001.4 mL in 1 POUCH; Type 0: Not a Combination Product04/16/2019
    2NDC:0924-7112-0110 in 1 CARTON04/16/2019
    21.4 mL in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0924-7112-0210 in 1 CARTON04/16/2019
    31.4 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0924-7112-0325 in 1 CARTON04/16/2019
    41.4 mL in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0924-7112-0450 in 1 CARTON04/16/2019
    51.4 mL in 1 POUCH; Type 0: Not a Combination Product
    6NDC:0924-7112-05100 in 1 CARTON04/16/2019
    61.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/16/2019
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-7112) , repack(0924-7112)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-7112) , repack(0924-7112)
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