BZK (BENZALKONIUM CHLORIDE) LIQUID [ME4KIDS]

BZK (BENZALKONIUM CHLORIDE) LIQUID [ME4KIDS]
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NDC 69535-413-01
Set ID 3071b8d1-938a-4ae1-bc80-0c8a1891ba1b
Category HUMAN OTC DRUG LABEL
Packager Me4Kids
Generic Name
Product Class
Product Number
Application Number PART333E
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    First Aid Antiseptic

  • Uses

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

  • Directions

    • tear open packet unfold and use as a washcloth. Allow hands to dry without wiping.
  • Inactive ingredients

    alcohol, purified water

  • Principal Display Panel - Packet Label

    Antiseptic
    Towelette

    Sting-free

    For Professional and Hospital Use

    Contents: 1 single use, premoistened towelette

    Distributed by ME4KIDZ | Phoenix, Arizona

    480-444-2332 | www.me4kidz.com

    Principal Display Panel - Packet Label
  • INGREDIENTS AND APPEARANCE
    BZK 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69535-413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride0.0013 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69535-413-012.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/21/2015
    Labeler - Me4Kids (167250534)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69535-413)

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