Label: ANTISEPTIC- benzalkonium chloride liquid 

  • Label RSS
  • NDC Code(s): 52116-7100-1
  • Packager: MAC Medical Supply Company, Inc.
  • 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 02/13

If you are a consumer or patient please visit this version.

  • 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 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.
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  • Inactive ingredients

    purified water, alcohol

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  • 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
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  • 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
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  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52116-7100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    benzalkonium chloride (benzalkonium) benzalkonium chloride 1.2478 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    alcohol  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52116-7100-1 100 in 1 BOX
    1 0.0025 L in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 05/05/2011
    Labeler - MAC Medical Supply Company, Inc. (118242200)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(52116-7100)
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