Label: PROSTAT ANTISEPTIC FIRST AID- benzocaine and benzethonium chloride aerosol, spray

  • 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 March 7, 2014

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  • Active Ingredients

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

  • Purpose

    Topical antiseptic
    Topical anesthetic 

  • Uses

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

  • Warnings

    For external use only

    Flammable
    Keep away from fire or flame
    Contents under pressure
    Do not puncture or incinerate container
    Do not expose to temperatures above 120° F 

  • Do not use

    In or eyes or near mucous membranes
    For 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
    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

    Hold 4-6 inches from surface
    Spray area until wet
    Clean the affected area
    Shake can well before using
    For adult institutional use only
    Not intended for use on children 

  • Other information

    Avoid inhaling
    Use only as directed
    Intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal

  • Inactive ingredients

    dipropylene glycol, isobutane, n-butane, propane

  • Principal Display

    image description

  • INGREDIENTS AND APPEARANCE
    PROSTAT ANTISEPTIC FIRST AID 
    benzocaine and benzethonium chloride aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-0104(NDC:52982-100)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE170 mg  in 85 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE8500 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:58228-0104-385 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/18/2014
    Labeler - ProStat First Aid (061263699)
    Registrant - Dixon Investments, Inc. (115315822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments, Inc.115315822manufacture(58228-0104)
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