DETTOL FRESH

Main information

  • Trade name:
  • DETTOL FRESH
  • Dosage:
  • 4 %w/v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/005/001
  • Authorization date:
  • 25-11-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0979/005/001

CaseNo:2032524

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrants

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DettolFresh4%w/vConcentrateforCutaneousSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjectto

thegeneralconditionsasmaybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom06/02/2007until24/11/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

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

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DettolFresh4%w/vConcentrateforCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Benzalkoniumchloride4.0%w/v.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

ConcentrateforCutaneoussolution

Aclear,colourlessconcentrateforcutaneoussolutionwithacharacteristiclemon/pineodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantisepticforprophylaxisoftopicalinfectioninintactandabradedskinandforskinpreparation

priortosurgicalordiagnosticprocedure.

4.2Posologyandmethodofadministration

Routeofadministration–topicaltorelevantareas.

Dilutionsforuse–applicationasrequired:

Woundcleansinganddisinfection

5%(1in20).50mltoonelitre,onetablespoontohalfapint.Abrasions,bathingandirrigationof

wounds,cutsandbites,spotsandpimples(noteczematousconditions).

Externalantisepsis

2.5%(1in40).25mltoonelitre,onetablespoontoonepint.Routineuseinobstetricsand

midwifery.

4.3Contraindications

Useinpatientshypersensitivetotheactiveingredient.

Irish Medicines Board

______________________________________________________________________________________________________________________

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

4.4Specialwarningsandprecautionsforuse

Labelwarnings

Forexternaluseonly.

Ifswallowed,washoutmouthanddrinkplentyofwaterormilk.Ifcontactismadewitheyes,wash

thoroughlywithcoldwater.

Inbothcases,consultyourdoctorandtakethisbottlewithyou.

Iftheconditionpersistsorisaggravated,discontinueuseandconsultthedoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

4.6Pregnancyandlactation

Notapplicable.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Notapplicable.

4.9Overdose

IntheeventofaccidentalingestionofsmallquantitiesofDettolFresh,transientemeticandpurgative

effectsmayoccurforwhichtherecommendedtreatmentistheadministrationofademulcent(e.g.

milk).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Benzalkoniumchlorideisaquaternaryammoniumcompoundwhichhasbeenusedformanyyearsas

asurfactantandantiseptic/disinfectant.

5.2Pharmacokineticproperties

Quaternaryammoniumcompoundssuchasbenzalkoniumchlorideareonlyabsorbedtoaverysmall

extentthroughhumanskinandthereforepharmacokineticstudieshavenotbeencarriedout.

Irish Medicines Board

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

Nopreclinicalfindingsofrelevancehavebeenreported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Propyleneglycol

Isopropylalcohol

Perfumefresh

Water

6.2Incompatibilities

DettolFreshisincompatiblewithsoapsandotheranionicsurfactants.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

GreentintedPVCbottlewithapolypropylenescrewcapwithapolyethyleneorPVDCwad.

Packsizes:125ml,250ml,500mland750ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerials

derivedfromsuchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

7Riverwalk

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

______________________________________________________________________________________________________________________

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

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25November1992

Dateoflastrenewal:25November2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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