BZK TOWELETTE (BENZALKONIUM CHLORIDE) SWAB [ACME UNITED CORPORATION]

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BZK TOWELETTE (BENZALKONIUM CHLORIDE) SWAB [ACME UNITED CORPORATION]
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NDC 0924-7112-00, 0924-7112-01, 0924-7112-02, 0924-7112-03, 0924-7112-04, 0924-7112-05
Set ID 866fdc1e-19b2-4d79-e053-2a91aa0a36fe
Category HUMAN OTC DRUG LABEL
Packager Acme United Corporation
Generic Name
Product Class
Product Number
Application Number PART333A
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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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