YOUR LOGO HERE ANTISEPTIC FIRST AID (BENZALKONIUM CHLORIDE AND LIDOCAINE) SPRAY, METERED [DIXON INVESTMENTS, INC.]

YOUR LOGO HERE ANTISEPTIC FIRST AID (BENZALKONIUM CHLORIDE AND LIDOCAINE) SPRAY, METERED [DIXON INVESTMENTS, INC.]
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NDC 52982-120-12, 52982-120-13
Set ID ecda79f9-1bfc-4890-b18e-9fbe0fec2b01
Category HUMAN OTC DRUG LABEL
Packager Dixon Investments, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active Ingredients

    Benzalkonium Chloride 0.14%
    Lidocaine 2.5%

  • Purposes

    Topical Antiseptic
    Topical Anesthetic

  • Uses

    Treatment of minor cuts and abrasions
    Pain Relief
    Helps prevent infection
    Soothes itching

  • Warnings

    For external use only

  • Do not use

    In eyes or near mucous membranes
    For serious burns
    Deep puncture wounds
    For 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
    YOUR LOGO HERE ANTISEPTIC FIRST AID 
    benzalkonium chloride and lidocaine spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:52982-120-1390 mL in 1 BOTTLE, SPRAY
    2NDC:52982-120-1260 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/05/2013
    Labeler - Dixon Investments, Inc. (115315822)
    Registrant - Dixon Investments, Inc. (115315822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments, Inc.115315822manufacture(52982-120)

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