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 October 5, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:

     Benzalkonium Chloride, 0.133% w/v



  • PURPOSE

    PURPOSE:

    First Aid Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

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

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Contains 1 Pad

    DIRECTIONS: Tear open packet, unfold and use as washcloth

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT: Distilled Water

  • PRINCIPAL DISPLAY PANEL - Pouch Label

    HENRY SCHEIN®
    112-5824

    NDC 0404-5824-01

    BZK
    TOWELETTE

    Contains Benzalkonium Chloride
    For External Use Only
    NON-STERILE

    Contains
    1 Pad

    CE

    Distributed by:

    HENRY SCHEIN INC.
    Melville, NY 11747 USA
    EC REP

    Henry Schein U.K. Holdings Ltd.
    Gillingham ME8 0SB U.K.

    Principal Display Panel - Pouch Label
  • INGREDIENTS AND APPEARANCE
    BZK TOWELETTE 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-5824
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM0.001 mL  in 1.4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-5824-011 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/05/2011
    Labeler - Henry Schein Inc. (012430880)
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