Label: BZK- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Benzalkonium Chloride 0.13%

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  • Purpose

    First Aid Antiseptic

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  • Uses

    • Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water
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  • Warnings

    For external use only.

    Do not use in the eyes. If this happens, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or redness develop and persists for more than 72 hours

    Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away

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  • Directions

    • Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

    Inactive ingredients purified water, alcohol

    Made in USA

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  • PRINCIPAL DISPLAY PANEL – box label

    Henry Schein

    NDC 0404-6735-01

    BZK TOWELETTE

    112-6735

    Contains Benzalkonium Chloride
    For External Use Only • Non-Sterile

    TOALLITA BZK No Estéril
    Contiene chloruro de benzalconio
    Destinado solo para uso externo

    SERVIETTA BZK No Stériles
    Contient du chlorure de benzalkonium
    Réservé á un usage externe

    100 Packets/Sobres/Sachet

    PRINCIPAL DISPLAY PANEL – box label
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  • PRINCIPAL DISPLAY PANEL – packet label

    Henry Schein

    NDC 0404-6735-01

    BZK TOWELETTE

    112-6735

    Contains Benzalkonium Chloride
    For External Use Only • Non-Sterile

    TOALLITA BZK No Estéril
    Contiene chloruro de benzalconio
    Destinado solo para uso externo

    SERVIETTA BZK No Stériles
    Contient du chlorure de benzalkonium
    Réservé á un usage externe

    Contains: 1 single-use, premoistened towelette

    Distributed by: Distribuldo por: Distribué par:
    HENRY SCHEIN, Inc. 135 Duryea Road Melville, NY 11747 USA

    PRINCIPAL DISPLAY PANEL – packet label
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  • INGREDIENTS AND APPEARANCE
    BZK 
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0404-6735
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    benzalkonium chloride (benzalkonium) benzalkonium chloride 0.0013 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    water  
    alcohol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0404-6735-01 100 in 1 BOX
    1 2.5 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/07/2013
    Labeler - Henry Schein Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(0404-6735)
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