Label: ANTISEPTIC- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 February 12, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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 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

    purified water, alcohol

  • PRINCIPAL DISPLAY PANEL – packet label

    MAC Medical

    Benzalkonium Chloride
    Antiseptic
    Towelette

    For Professional and Hospital Use

    Contents: 1 single-use, premoistened towelette

    Manufactured for MAC Medical Supply Company, Inc.
    Chicago, IL 60661 800-523-8337

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

    NDC 61010-7110-1

    MAC Medical

    Benzalkonium Chloride
    Antiseptic
    Towelette

    For Professional and Hospital Use

    Contents: 100 single-use, premoistened towelettes

    Reorder No. BZK-100

    PRINCIPAL DISPLAY PANEL – box label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52116-7100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.2478 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52116-7100-1100 in 1 BOX
    10.0025 L in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/05/2011
    Labeler - MAC Medical Supply Company, Inc. (118242200)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(52116-7100)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!