BURNEZE SPRAY 1 %w/w Cutaneous Spray Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
BENZOCAINE
Available from:
SSL International PLC
INN (International Name):
BENZOCAINE
Dosage:
1 %w/w
Pharmaceutical form:
Cutaneous Spray Solution
Prescription type:
Product not subject to medical prescription
Authorization status:
Authorised
Authorization number:
PA0618/002/001
Authorization date:
0000-00-00

BURNEZESPRAY

Benzocaine1.0% w/w

PATIENTINFORMATION LEAFLET

Please readthis leafletcarefullybefore usingBurneze Spray.

Keepthis leaflet,you may wish to readitagain.

Askyourpharmacist ifyou needmore information oradvice.

Whatis thisspray usedfor?

Burneze Spray contains local anaesthetic called Benzocaine which relieves pain.

This spray solutionis applied to the skinto relieve pain fromminorsuperficial

burns andscalds,where the skinis unbroken.

Before usingthis spray

Donot use…

Ifyou are allergic to anyofthe ingredients inthis product orany

chemicallyrelatedanaesthetics (butylcaineandtetracaine) orpara-

aminobenzoic acid,parabens orparaphenylenediamineorto commercial

hair dyes.See'what this spray contains'forthe full list ofingredients.

On large areas oronbrokenskinoron infectedskin.

In ornear to the eyes ormouth,orunder conditions in which significant

inhalation is likely.

Take special care…

Ifyou are pregnant orbreast feedingspeakto yourdoctororpharmacist

before using.

Burneze spray is forexternal use only.

Avoidfreezingthe skinbyrepeatedorprolongeduse.

Seekmedical attentionifthe burns are extensive (especiallyinyoung

childrenorif they affectfingers,toes orsensitive areas).

Howto use this spray

To reduce pain andblistering use Burneze spray as quicklyas possible.

Holdthe nozzle 12.5cm(5inches) fromthe skin.

Press down firmlyandspray once for2to 3seconds.

Stopspraying straight away ifa white deposit or ‘frost’ appears.

Ifnecessarythe application maybe repeatedonce onlyafter15minutes.

Ifpain persists,speakto yourdoctororpharmacist.

Possible side effects

As with all medicines,this spray canhave side effects insome people.

In sensitive people it may allergic skin reactions,suchas itching,redness,

blisters,nettlerash (hives).

Ifyoufeel you arereacting badlyto this medicineinanyway,ornoticeanyother

side effects notlistedinthis leaflet,please tell yourdoctororpharmacist.

Howto store this spray

Keepout of the sight andreachofchildren.

Donot store above 25°Candkeepawayfrom heat andsunlight.

Caution Flammable:Donot usenear fire orflame.

Pressurisedcontainer.Protect fromsunlight anddo notexpose to

temperatures exceeding50°C.Donot pierce orburn,even afteruse.Do

notuse near orplace containeron polishedorpaintedsurfaces.

Donot useafterexpirydate shown baseofthe can.

Ifyoufindthatyou stillhave this medicineafterits expirydate,return it

to yourlocal pharmacist who willdispose ofitproperly.

Whatthis spray contains

Burneze spray contains % byweight ofthe active ingredientbenzocaine.

It also contains denaturedethanol,n-pentane andiso-butane.

The physical effectofthe cooling excipients helps reduce pain andblistering.

Burneze spray is available in aluminium cans containing 60mlofcutaneous

spray,solution to beapplied topicallyto the affectedarea.

MarketingAuthorisation Holder:Seton Products Ltd,Tubiton House,Oldham

OL13HS,UK

Manufacturedby:ColepCCLRapid-Spray GmbH& Co.KG,Fockestrasse12,

88471Laupheim,Germany.

Dateofrevision: July2013

Burneze is a trade markofthe SSLGroup.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BurnezeSpray

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Benzocaine1%w/w.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneousspray,solution.

Clear,colourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthesymptomaticreliefofpainfromminorsuperficialburnsandscaldswheretheskinisunbroken.

4.2Posologyandmethodofadministration

Methodofadministration:fortopicaladministration.

Adults,theelderlyandchildren:

ToreducepainandblisteringuseBurnezeSprayasquicklyaspossible.

Holdnozzlefiveinches(10cm)fromtheskinandsprayoncefor2-3seconds.Stopsprayingimmediatelyifawhite

frostdeposit(frost)appears.Ifnecessary,theapplicationmayberepeatedonceonlyafter15minutes.Ifpainpersists

seekmedicaladvice.

4.3Contraindications

Donotuseifyouaresensitivetobenzocaineoranychemicallyrelatedanaesthetics(butylcaineandtetracaine).

DonotuseifyouaresensitivetoanyoftheexcipientsortoPABA,parabensorparaphenylenediamineorto

commercialhairdyesasthereiscross-sensitivitybetweentheseproducts.

Donotuseonbrokenorinfectedskin.

4.4Specialwarningsandprecautionsforuse

Patientswithanyknownallergyshouldseekmedicaladvice.Donotapplytolargeareasortobrokenskin.Donotuse

inornearthemouthoreyesorunderconditionsinwhichsignificantinhalationislikely.

Avoidfreezingtheskinbyrepeatedorprolongeduse.Seekmedicaladviceimmediatelyifburnsareextensive

(particularlyinyoungchildrenoriftheyaffectfingers,toesorsensitiveareas).

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/08/2013 CRN 2130771 page number: 1

Flammable.Donotusenearfireorflame.Pressurisedcontainer.Protectfromsunlightanddonotexposeto

temperaturesexceeding50°C.Donotpierceorburn,evenafteruse.Donotsprayonanakedflameorany

incandescentmaterial.Donotusenearorplacecontaineronpolishedorpaintedsurfaces.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Pregnancy:

Therearenoorlimitedamountofdata(lessthan300pregnancyoutcomes)fromtheuseofbenzocaineinpregnant

women.Asaprecautionarymeasure,itispreferabletoavoidtheuseofbenzocaineduringpregnancy.

Lactation:

Thereisinsufficientinformationontheexcretionofbenzocaineoritsmetabolitesinhumanmilk.Adecisionmustbe

madewhethertodiscontinuebreast-feedingortodiscontinue/abstainfrombenzocainetherapytakingintoaccountthe

benefitofbreastfeedingforthechildandthebenefitoftherapyforthewomen.

Fertility:

Thereisnoknowneffectonfertility.

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

Maycauseallergicdermatitisinsensitiveindividuals.

Hypersensitivityreactionsarerareandgenerallylimitedtolocalanaestheticsoftheestertype.

Thereappearstobenocross-sensitivitybetweenester-andamidetypelocalanaesthetics.Idiosyncrasytolocal

anaestheticshasbeenreported.

4.9Overdose

Anoverdoseisextremelyunlikelywiththistypeofpreparation.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Benzocaine,ATCcode:D04AB04

Theactiveingredient,benzocaine,isalocalanaestheticwhichrelievespain.Thephysicaleffectsofthecooling

propellantshelpreducepainandblistering.

Benzocainecausesareversibleblockadeofnerveconductionbydecreasingnervemembranepermeabilitytosodium,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/08/2013 CRN 2130771 page number: 2

5.2Pharmacokineticproperties

BurnezeSprayisappliedtopicallytotheaffectedarea.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol,denatured

Iso-butane

N-pentane

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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/08/2013 CRN 2130771 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 09July1996

Dateoflastrenewal: 09July2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/08/2013 CRN 2130771 page number: 4

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