YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]

YOUR LOGO HERE BURN FIRST AID (BENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOL) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]
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NDC 52982-101-01, 52982-101-03
Set ID 57d1a917-d635-4e7b-a49a-6b3d175af326
Category HUMAN OTC DRUG LABEL
Packager Dixon Investments, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Benzocaine 10% w/w
    Benzethonium Chloride .2% w/w
    Menthol .33% w/w 

  • Purpose

    Topical Anesthetic
    Topical Anesthetic
    Topical Anesthetic 

  • Uses

    For temporary relief of pain and ithcing and help protect against infection in
    minor cuts and scrapes
    burns
    sunburnsinsect bitesminor skin irritations

  • Warnings

    For external use only

    Flammable

    keep away from fire or flame

  • Do not use

    in or near eyes or other mucous membranes
    in case of serious burns in deep puncture wounds
    for a prolonged period of time
    on large portions of the body 

  • When using this product

    avoid spraying in eyes
    contents under pressuredo not puncture or incinerate containerdo not store at temperatures above 120°(F)use only as directedintentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal 

  • Stop use and ask doctor if

    redness, swelling, or irritation occurs
    infection occurs
    conditions worsens or symptoms persist for more than 7 days 

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    clean the affected area
    shake can well before using
    hold 4-6 inches from surface and spray area until wet
    for adult institutional use only
    not intended for use on children 

  • Inactive Ingredient

    Dipropylene glycol, isobutane, n-butane, and propane

  • Principal Display

    image description

  • INGREDIENTS AND APPEARANCE
    YOUR LOGO HERE BURN FIRST AID 
    benzocaine, benzethonium chloride, and menthol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52982-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE8500 mg  in 85 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE170 mg  in 85 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL281 mg  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52982-101-0385 g in 1 BOTTLE, SPRAY
    2NDC:52982-101-0114.2 g 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(52982-101)

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