Label: NORTH ANTISEPTIC FIRST AID- benzalkonium chloride and lidocaine spray, metered

  • 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 May 16, 2014

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  • Active Ingredients

    Benzalkonium Chloride 0.14%
    Lidocaine 2.5%

  • Purpose

    Topical Antiseptic
    Topical Anesthetic

  • Uses

    • treatment of minor cuts, scratches and burns
    • pain relief
    • helps prevent infection
    • soothes itching
  • Warnings

    For external use only

  • Do not use

    • in eyes or near mucous membranes
    • serious burns
    • deep puncture wounds
    • for a prolonged period of time
  • Stop use and ask a doctor if

    • irritation, redness, or swelling increases
    • rash or infection occurs
  • Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Hold 4-6 inches from surface
    • Spray area until wet
  • Inactive Ingredients

    Isopropyl Alcohol, Water

  • Principal Display

    image description

  • INGREDIENTS AND APPEARANCE
    NORTH ANTISEPTIC FIRST AID 
    benzalkonium chloride and lidocaine spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0016(NDC:52982-120)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1912.5 mg  in 90 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE107.1 mg  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0016-1060 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/29/2014
    Labeler - North Safety Products, LLC. (019777263)
    Registrant - Dixon Investments, Inc. (115315822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments, Inc.115315822manufacture(0498-0016)
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