Label: ANTISEPTIC- benzalkonium chloride liquid

  • 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 November 20, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    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

    FIRST AID ONLY®

    Antiseptic
    Towelette

    Benzalkonium Chloride (BZK)

    1 Premoistened Towelette

    Package not Child-Resistant

    www.FirstAidOnly.com

    Fairfield, CT 06824

    1.800.835.2263

    © 2015 Acme United Corporation.

    Principal Display Panel - Packet Label
  • Principal Display Panel - Box Label

    FIRST AID ONLY®

    51028

    ANTISEPTICS

    BZK Antiseptic Towelettes

    25 Wipes

    Toallitas húmedas antisépticas con cloruro de benzalconio

    25 toallitas

    Principal Display Panel - Box Label
  • Principal Display Panel - Box Label

    J308
    ANTISEPTICS

    First Aid Only®

    BZK Antiseptic
    Towlettes

    100 Wipes

    Toallitas húmedas antisépticas
    con cloruro de benzalconio

    100 toallitas

    Principal Display Panel - Box Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-7110
    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:0924-7110-0150 in 1 BOX
    1NDC:0924-7110-000.0025 L in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-7110-0210 in 1 BOX
    2NDC:0924-7110-000.0025 L in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-7110-0325 in 1 BOX
    3NDC:0924-7110-000.0025 L in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-7110-0410 in 1 BOX
    4NDC:0924-7110-000.0025 L in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-7110-0525 in 1 BOX
    5NDC:0924-7110-000.0025 L in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-7110-0650 in 1 BOX
    6NDC:0924-7110-000.0025 L in 1 PACKET; Type 0: Not a Combination Product
    7NDC:0924-7110-07100 in 1 BOX
    7NDC:0924-7110-000.0025 L in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/20/2012
    Labeler - Acme United Corporation (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0924-7110)
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