DETTOL ANTISEPTIC

Main information

  • Trade name:
  • DETTOL ANTISEPTIC
  • Dosage:
  • 0.3/0.3/0.2 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DETTOL ANTISEPTIC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/004/001
  • Authorization date:
  • 23-10-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0979/004/001

CaseNo:2051147

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DettolAntisepticCreamChloroxylenol0.3%w/wTriclosan0.3%w/wEdeticAcid0.2%w/w

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom23/10/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/01/2009 CRN 2051147 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DettolAntisepticCream

Chloroxylenol0.3%w/w

Triclosan0.3%w/w

EdeticAcid0.2%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ContainsCetostearylAlcohol(aconstituentofEmulsifyingWax)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

Awhite,water-misciblecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantisepticforthetopicaltreatmentofskininjuries.

4.2Posologyandmethodofadministration

Forthetopicalapplicationtotheskin.

Adultsandchildren:Afterthoroughcleansing,applyinsmallamountsdirectlyontheskinasrequired.

Thereisnoindicationthatdosageneedbemodifiedfortheelderly.

4.3Contraindications

Knownhypersensitivitytotheactiveingredients

Allergicskinreactions,dermatitis,eczemaorotherskincomplaints.

4.4Specialwarningsandprecautionsforuse

Ifthereisnoimprovementortheconditionisaggravated,consultthedoctor.

Creamcontaining:

Chloroxylenol

Triclosan

Edeticacid(asthepotassiumsalt) 0.30

0.30

0.20 %w/w

%w/w

Irish Medicines Board

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lukewarmwater.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Thereisinadequateevidenceofthesafetyofthedruginhumanpregnancyandlactation,buttherehasbeenwideusein

humanswithoutapparentillconsequence.Animalstudieshaveshownnohazard.Ifdrugtherapyisneededin

pregnancythisdrugcanbeusedifthereisnosaferalternative.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Noneknown.

4.9Overdose

Itisunlikelythatasufficientvolumeofthecreamcouldbeingestedtocauseanymedicalproblems.Intheeventof

accidentaleyecontact,washwithlukewarmwater.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ChloroxylenolisanantisepticagentwhoseactivityisprincipallyagainstStreptococci,butalsohassomeactivity

againstStaphylococci.TriclosanexhibitsbacteriostaticactivityagainstawiderangeofGrampositiveandGram

negativeorganisms.TheseactiveingredientsarethemselvesresistanttothePseudomonasspecies,butinclusionof

EDTApotentiatestheiractivityagainstthisorganism.

5.2Pharmacokineticproperties

Animalstudieshaveshownthatfollowingdermalapplicationchloroxylenolisrapidlyabsorbed(Cmax=1-2hours),

extensivelymetabolisedandexcretedviathekidneywithalmostcompleteeliminationwithin24hours.Inman,similar

applicationoftriclosanresultedinonlyminimalpercutaneousabsorption(around5%)following24hourocclusionto

theskin.Subsequentmetabolismoccursslowly(T½=10hours),followedbyrapidurinaryexcretion,principallyas

theglucuronide.

5.3Preclinicalsafetydata

Irish Medicines Board

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Emulsifyingwax(containscetostearylalcohol)

Carbomer974P

Glycerol

AlmondOil,Refined

Terpineol

PerfumeblendA2(perfume8399,perfumeES9078,perfume2336A)

Potassiumhydroxidesolution50%(forpHadjustment)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Collapsiblealuminiumtubewithaninternallacquercoating.

Packsize-30g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited,

7Riverwalk

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA979/4/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 23 rd

October1978

Dateoflastrenewal: 23 rd

Irish Medicines Board

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10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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