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 June 4, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    First Aid Antiseptic

  • Uses

    • First aid to help prevent infection in minor cuts, scrapes and burns
  • Warnings

    For external use only

    Do not use

    • in the eyes, or apply over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • condition persists or gets worse

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

  • Directions

    • clean the affected area
    • spray a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    • shake well
    • store at room temperature
  • Inactive ingredients

    purified water, alcohol

  • STORAGE AND HANDLING

    Store at room temperature

  • Questions or comments?

    1-800-327-2704

    Manufactured for: Respond Industries and American First Aid
    Mason, OH 45040
    #61025
    Rev 04/13

  • PRINCIPAL DISPLAY PANEL – bottle label

    Antiseptic
    Spray

    FIRST AID ANTISEPTIC
    Convenient pump
    spray allows no-touch
    application. Use as a
    first aid treatment to
    help prevent infection
    in cuts and scrapes.

    2 fl. oz. (59.1 mL)

    PRINCIPAL DISPLAY PANEL – bottle label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-7120
    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:68421-7120-10.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/02/2013
    Labeler - Cintas First Aid & Safety (056481716)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(68421-7120)
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