COLGATE TOTAL FRESH STRIPE TOOTHPASTE

Main information

  • Trade name:
  • COLGATE TOTAL FRESH STRIPE TOOTHPASTE
  • Dosage:
  • 0.3/0.32 %w/w
  • Pharmaceutical form:
  • Toothpaste
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COLGATE TOTAL FRESH STRIPE TOOTHPASTE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0320/005/002
  • Authorization date:
  • 20-12-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ColgateTOTALFreshStripeToothpaste

2QUALITATIVEANDQUANTITATIVECOMPOSITION

TheactiveingredientsofColgateTOTALFreshStripeToothpasteare:

Triclosan0.300%w/w.

Sodiumfluoride0.32%w/w(equivalentto1450p.p.m.fluoride).

Forafulllistofexcipients.See6.1.

3PHARMACEUTICALFORM

Toothpaste

Greenpearlescentcreamwithwhitestripes.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Toreducedentalcaries.

Toimprovegingivalhealthby:

Significantlyreducingtheformationofplaqueandcalculus.

Significantlyreducingexistinglevelsofgingivalbleedingandinflammation.

Toreducetheprogressionofperiodontitis.

4.2Posologyandmethodofadministration

Fordentaluse.

Theusualdosageistoapplyaribbonoftoothpasteacrosstheheadofthetoothbrush(approximately1.0g)andtobrush

theteethforoneminutetwicedaily.

Childrenunder7,useapea-sizedamountforsupervisedbrushing.Ifusingfluoridesupplementsconsultyourdentist.

4.3Contraindications

Noneknown.

Individualswithknownsensitivitiesshouldconsultwiththeirdentistbeforeusing.

4.4Specialwarningsandprecautionsforuse

Childrenunder7,useapea-sizedamountforsupervisedbrushingtominimiseswallowing.Ifusingfluoride

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Date Printed 28/02/2011 CRN 2085228 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.Itisimportanttonotethatasforanyfluoridecontainingtoothpaste,inchildrenundersystemicfluoride

therapy,itisimportanttoevaluatethetotalexposuretofluoride(fluorosis).

4.6Fertility,pregnancyandlactation

Useofthisproductisnotcontraindicatedduringpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Noneknown.

4.9Overdose

Notapplicable.Useofthistypeofproductwouldnotbeexpectedtoresultinanoverdose.

Noacuteeffectswouldbeexpectedfromthelowleveloftriclosan(489mgina125mltube).Evenintheextremecase

ofprolongedexposure,seriousadverseeffectswouldnotbeexpectedfromtriclosan.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:A01AA01.

Triclosan:Triclosanisabroad-spectrumnon-ionicantibacterialwithactivityagainstbothaerobicandanaerobic

gram-positiveandgram-negativemicrobes.Itiswidelyemployedasadisinfectantandasananti-bacterialinexternal

useOTC(overthecounter)products.InColgateTotalFreshStripeToothpasteitiscombinedwithacopolymerwhich

enhancesthedeliveryoftriclosantothesiteofaction.

SodiumFluoride:SodiumFluorideappliedtopicallyaftertootheruptionreducescariesbyinhibitingdemineralisation

andpromotingremineralisationofthetoothsurfaceandbyinhibitingthecariogenicmicrobialprocess.

5.2Pharmacokineticproperties

Triclosan:Whenadministeredinadentifricebytoothbrushing,salivaryandplaquetriclosanlevelsrangebetween1-6

ppmand25ppmrespectivelyat1-2hoursafterusinga0.3%dentifrice.Followingusageofadentifricecontainingup

to0.6%triclosan,meanbloodlevelsrangebetween15to25ppb.

Bloodlevelsoftriclosaninsubjectsbrushingwithadentifriceareabout14percentofthoseinsubjectswhodirectly

ingestedanaqueoussolutioninanequivalentdoselevel.

SodiumFluoride:Afteroraladministration,fluorideabsorptionisrapidandextensivewith(90-100%)peakfluoride

plasmalevelsreachedwithin30to60minutesafteringestion.Fluorideiswidelydistributedthroughthebodyand

concentratesintheboneandteeth.About50%offluorideabsorbedisstored.Excretionisprimarilythroughthe

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5.3Preclinicalsafetydata

Triclosan:Insubchronicoralingestionstudieswithrats,dentifricescontainingtriclosanwereadministeredfor13

weeksatlevelsthatareconservativelyupto100timesexpectedhumanuselevels.Animalsreceiveddailydosesofup

to12mg/kgoftriclosanandshowednoindicationsoftreatmentrelatedeffects.Thisdosewouldbeequivalentto600

mgoftriclosanina50kghuman.

Ingestionof125mlofatoothpaste(approximatelyonetube)containing0.3%triclosanwouldgiveanintakeof

approximately489mgandwouldnotbeexpectedtoproduceuntowardeffects.

SodiumFluoride:Thetotalamountofsodiumfluorideina125mltubeofColgateTotalFreshStripeToothpasteis

516mg.Thisiswithintheacceptablelimitsfortheamounttobedispensedatonetimeforsafetypurposes.Prolonged

dailyingestionofexcessivefluoridemayresultinvaryingdegreesoffluorosis.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Silica,DentalType

Sorbitol(70%)Non-Crystallising

Purifiedwater

Poly(methylvinylether)maleicacid

Sodiumhydroxide(25%solution)

Sodiumlaurilsulfate

89-303CrispMintFlavour(greenstripe)*

89-3854MintFlavour(whitestripe)**

Carmellosesodium

Titaniumdioxide(E171)

Iotacarrageenan

Saccharinsodium

Titaniumdioxidecoatedmica

Aluminiumlakeofquinolineyellow(E104)

AluminiumlakeofBrilliantBlueFCF(E133)

*contains:menthol,peppermintoil,anethole,eugenol,cinnamicaldehyde

**contains:menthol,peppermintoil,anethole,spearmintoil,lemonoil,coolingagents,syntheticmint

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

ColgateTOTALFreshStripeToothpasteispackagedin19,50,75,100,125and150mllaydownfoillaminatetubes

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Conicalshoulderwiththreadedneckmanufacturedfromhighdensitypolyethylene,

Barriermaterialofpolybutylteraphthalate(PBT)orpolyesterteraphthalate(PET)belowandinsidetheconical

shoulder,

Cylindricallaminatedtubebody.

Thelaydownbodyismanufacturedfrom5-plylaminatedwebstockcomprisingfromoutsidetoinside:

Thestand-up-tubebodyismanufacturedfrompolyethylenelaminatecomprising:

Mediumdensitypolyethylene,

Ethylvinylalcoholbarrier,

Mediumdensitypolyethylene.

Thecapsaremanufacturedfrompolypropyleneandareeitherscreworsnap-on.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Colgate-Palmolive(UK)Ltd.

GuildfordBusinessPark

Guildford

SurreyGU28JZ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA320/5/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20December2000

Dateoflastrenewal:20December2005

10DATEOFREVISIONOFTHETEXT

Outerlayer: Polyethylene,

Adhesioncopolymer,

Aluminiumfoil,

Adhesioncopolymer.

Irish Medicines Board

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Date Printed 28/02/2011 CRN 2085228 page number: 4