BURNEZE SPRAY

Main information

  • Trade name:
  • BURNEZE SPRAY
  • Dosage:
  • 1 %w/w
  • Pharmaceutical form:
  • Cutaneous Spray Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BURNEZE SPRAY
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0618/002/001
  • Authorization date:
  • 09-07-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BurnezeSpray

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Benzocaine1%w/w.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneousspray,solution.

Clear,colourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthesymptomaticreliefofpainfromminorsuperficialburnsandscaldswheretheskinisunbroken.

4.2Posologyandmethodofadministration

Forcutaneoususe.

Adults,theelderlyandchildren:

ToreducepainandblisteringuseBurnezeSprayasquicklyaspossible.

Holdnozzlefiveinchesfromtheskinandsprayoncefor2-3seconds.Stopsprayingimmediatelyifawhitefrost

deposit(frost)appears.Ifnecessary,theapplicationmayberepeatedonceonlyafter15minutes.Ifpainpersistsseek

medicaladvice.

4.3Contraindications

Donotuseifyouaresensitivetobenzocaine.

4.4Specialwarningsandprecautionsforuse

Patientswithanyknownallergyshouldseekmedicaladvice.Donotapplytolargeareasortobrokenskin.Donotuse

inornearthemouthoreyesorunderconditionsinwhichsignificantinhalationislikely.

Avoidfreezingtheskinbyrepeatedorprolongeduse.Seekmedicaladviceimmediatelyifburnsareextensive

(particularlyinyoungchildrenoriftheyaffectfingers,toesorsensitiveareas).

Forexternaluseonly.Keepoutofthereachofchildren.

Flammable.Donotusenearfireorflame.Pressurisedcontainer.Protectfromsunlightanddonotexposeto

temperaturesexceeding50°C.Donotpierceorburn,evenafteruse.Donotsprayonanakedflameorany

Irish Medicines Board

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Date Printed 07/07/2011 CRN 2094558 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Safetyofuseinpregnancyandlactationhasnotbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

Maycauseallergicdermatitisinsensitiveindividuals.

4.9Overdose

Anoverdoseisextremelyunlikelywiththistypeofpreparation.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Benzocaine,ATCcode:D04AB04

Theactiveingredient,benzocaine,isalocalanaestheticwhichrelievespain.Thephysicaleffectsofthecooling

propellantshelpreducepainandblistering.

5.2Pharmacokineticproperties

BurnezeSprayisappliedtopicallytotheaffectedarea.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol,denatured

Iso-butane

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6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Thecanistercontainsapressurisedliquid.

Donotexposetotemperatureshigherthan50°C.Donotpiercethecanister.

6.5Natureandcontentsofcontainer

Aluminiumcansinternallycoatedwithepoxyphenoliclacquerfittedwithvalveassemblyandactuatorbutton,protected

byapolypropyleneplasticcapcontaining60mlor200mlofsolution.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

SetonProductsLimited

TubitonHouse

OldhamOL13HS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0618/002/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 09July1996

Dateoflastrenewal: 09July2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 07/07/2011 CRN 2094558 page number: 3