Label: YOUR LOGO HERE ANTISEPTIC FIRST AID- benzocaine and benzethonium chloride aerosol, spray

  • NDC Code(s): 52982-100-03
  • Packager: Dixon Investments, Inc.
  • 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 January 9, 2023

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  • Active Ingredients

    Benzocaine 10% w/w
    Benzethonium Chloride 0.2% w/w 

  • Purpose

    Topical Anesthetic
    Topical Antiseptic 

  • Uses

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

  • 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 the eyes
    contents under pressure
    do not puncture or incinerate container
    do not store at temperatures above 120°F
    use only as directed
    intentional 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
    condition 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 ANTISEPTIC FIRST AID 
    benzocaine and benzethonium chloride aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52982-100
    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
    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:52982-100-0385 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2012
    Labeler - Dixon Investments, Inc. (115315822)
    Registrant - Dixon Investments, Inc. (115315822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments, Inc.115315822manufacture(52982-100)
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