Label: PROSTAT PROTECTIVE COATING BANDAGE FIRST AID- benzethonium chloride and benzocaine 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 February 24, 2014

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  • Active ingredients

    Benzethonium Chloride 0.2% w/w
    Benzocaine 3.2% w/w 

  • Purpose

    Topical antiseptic
    Topical anesthetic 

  • Uses

    First aid to help protect against infection in

    minor cuts
    scrapes
    burns 

  • 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 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 

  • Stop use and ask a doctor if

    redness, swelling, or irritation occurs
    infection occurs
    condition persists or worsens
    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 

  • Other information

    avoid inhaling
    use only as directed
    intentional misuse by deliberately concentrating and inhaling contents may be harmful or fatal 

  • Inactive ingredients

    Ethyl alcohol, PVP-VA copolymer, N-Butane, Propane, Isobutane

  • Principal Display

    image description

  • INGREDIENTS AND APPEARANCE
    PROSTAT PROTECTIVE COATING BANDAGE FIRST AID 
    benzethonium chloride and benzocaine aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-0102(NDC:52982-105)
    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) BENZOCAINE2720 mg  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-0102-385 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/18/2014
    Labeler - ProStat First Aid (061263699)
    Registrant - Dixon Investments, Inc. (115315822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments, Inc.115315822manufacture(58228-0102)
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