DETTOL ANTISEPTIC PAIN RELIEF SPRAY

Main information

  • Trade name:
  • DETTOL ANTISEPTIC PAIN RELIEF SPRAY
  • Dosage:
  • 2.2/ 0.395% %w/ v
  • Pharmaceutical form:
  • Cutaneous Spray Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DETTOL ANTISEPTIC PAIN RELIEF SPRAY
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/018/001
  • Authorization date:
  • 10-12-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0979/018/001

CaseNo:2032524

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrants

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DettolAntisepticPainReliefSpray

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjectto

thegeneralconditionsasmaybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom06/02/2007until09/12/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/04/2007 CRN 2032524 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DettolAntisepticPainReliefSpray.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cutaneousspray,solution.

Clearcolourlessliquidwithcharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheantisepticcleansingandpainreliefofminorwoundssuchascutsandskingrazes,insectbitesandstings,small

burnsandscalds.

4.2Posologyandmethodofadministration

Foradultsandchildren:Spraytheaffectedareaasneededandwipeawayanyexcessliquidwithcleantissueorcotton

wool.Repeatasnecessary.

4.3Contraindications

Noneknown.

4.4Specialwarningsandprecautionsforuse

Labelwarning:Forexternaluseonly.Donotusearoundtheeyesorears,inthemouthoroverlargeareasofthe

body.Donotinhale.Inthecaseofaccidentaleyecontact,theeyesshouldbeirrigatedwithcopiousamountsofcold

water.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Lidocainehydrochloride 2.2 %w/v

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/04/2007 CRN 2032524 page number: 2

Thereisnodirectevidenceontheuseoflidocainehydrochlorideinhumanpregnancy,butithasbeeninwideusefor

manyyearswithoutapparentillconsequence.Aswithallmedicines,theuseofDettolAntisepticPainReliefSprayis

contraindicatedinearlypregnancyunlessabsolutelyessential.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Noneknown.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

5.1.1.Benzalkoniumchloride

Benzalkoniumchlorideisaquaternaryammoniumcompoundwhichhasbeenusedformanyyearsas

asurfactantandantiseptic/disinfectant.Itisknowntobebactericidalinlowconcentrationstoawide

rangeofGrampositiveandGramnegativebacteria.

5.1.2.Lidocainehydrochloride

Lidocainehydrochlorideisanestablishedlocalanaestheticagentwhichproducestissueinsensitivitybyvirtueofits

abilitytoimpedetheinwardfluxofsodiumions,thuspreventingtransmissionofthenerveimpulse.

5.2Pharmacokineticproperties

5.2.1.Benzalkoniumchloride

Quaternaryammoniumcompoundssuchasbenzalkoniumchlorideareonlyabsorbedtoaverysmallextentthrough

humanskin.

5.2.2.Lidocainehydrochloride

Lidocainehydrochlorideisonlyveryslowlyabsorbedfromintactskinasitisnotlipophilic.

5.3Preclinicalsafetydata

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/04/2007 CRN 2032524 page number: 3

Thelowlevelofbenzalkoniumchlorideintheproduct,coupledwithitslowlevelabsorptionfrom

intactandbrokenskin,makeitunlikelythatanysignificantsystemictoxiceffectshouldarisefromits

use.Thereisevidencethatitcanhaveanirritanteffectonmucousmembranes.

5.3.2.Lidocainehydrochloride

Thelowleveloflidocainehydrochlorideintheproductandamountappliedtotheskinmakeitunlikelythatany

Irish Medicines Board

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Date Printed 13/04/2007 CRN 2032524 page number: 4

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Propyleneglycol

Sodiumdihydrogenphosphatedihydrate

Sodiumphosphate

Jumble2Gperfume

Disodiumedetate

Purifiedwater.

6.2Incompatibilities

Benzalkoniumchloridemaybedeactivatedwhenusedwithsoaporothersurfactants.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

None.

6.5Natureandcontentsofcontainer

WhiteHDPEcontainerwithaspraypump.Thepumpheadisprotectedbyaclear,polypropyleneco-polymerovercap.

Thepacksizeis50ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerials

derivedfromsuchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

7Riverwalk

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA979/18/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10 th

December1998

Dateoflastrenewal:10 th

Irish Medicines Board

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Date Printed 13/04/2007 CRN 2032524 page number: 5

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 13/04/2007 CRN 2032524 page number: 6