Label: FIRST AID ONLY BZK ANTISEPTIC TOWELETTES- 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 August 9, 2021

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.133%

    Purpose

    First Aid Antiseptic

  • Uses

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

  • Warnings

    Do not use

    • in the eyes
    • 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.

    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

    Purified Water, sodium bicarbonate

  • Questions

    1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    carton label Carton Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY BZK ANTISEPTIC TOWELETTES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-7115(NDC:59050-331)
    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 BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-7115-001.6 mL in 1 POUCH; Type 0: Not a Combination Product08/09/2021
    2NDC:0924-7115-0110 in 1 CARTON08/09/2021
    21.6 mL in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0924-7115-0225 in 1 CARTON08/09/2021
    31.6 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0924-7115-0350 in 1 CARTON08/09/2021
    41.6 mL in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0924-7115-04100 in 1 CARTON08/09/2021
    51.6 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 finalpart333E08/09/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-7115) , repack(0924-7115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-7115) , repack(0924-7115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation117825595relabel(0924-7115) , repack(0924-7115)
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