CALLOUS REMOVAL PADS 40 %w/w Impregnated Dressing

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
SALICYLIC ACID
Available from:
Scholl Consumer Products Limited
INN (International Name):
SALICYLIC ACID
Dosage:
40 %w/w
Pharmaceutical form:
Impregnated Dressing
Prescription type:
Product not subject to medical prescription
Authorization status:
Authorised
Authorization number:
PA0455/006/003
Authorization date:
0000-00-00

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0455/006/003

CaseNo:2035470

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

SchollConsumerProductsLimited

Venus,1OldParkLane,TraffordPark,Manchester,M417HA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CallousRemovalPads

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/06/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/04/2009 CRN 2035470 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CallusRemovalPads

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Medicatedplasters

Amedicatedplastermountedonasilicone-backedpaper.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofcallouses.

4.2Posologyandmethodofadministration

Adults

Forthebestresultsthefeetshouldbewashedanddriedbeforeuse.Onemedicateddiscshouldbeplacedonthecallous,

coveredwithacoverplaster.Thisshouldberepeateddailyuntilthecallouscanberemoved.Treatmentshouldnot

continueformorethantwoweeks,exceptundermedicaladvice.

Nodistinctionismadebetweendifferentcategoriesofpatient.

Children

Notrecommendedforchildrenunder16yearsofage,exceptfollowingadoctor’srecommendation.

4.3Contraindications

Nottobeusedbydiabeticsorthosewithseverecirculatorydisorders,exceptfollowingadoctor’spermissionand

recommendation.

Nottobeusedbythosesensitivetosalicylicacidoranyoftheotherconstituentsoftheproduct.

Nottobeusedifthecallousorsurroundingskinisbrokenorinflamed.

4.4Specialwarningsandprecautionsforuse

Discontinueuseandremoveplasterifexcessivediscomfortisexperienced.

Donotapplytonormalskin.

SalicylicAcid 40.00%w/w

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/04/2009 CRN 2035470 page number: 2

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notrelevanttocutaneoususe.

4.6Pregnancyandlactation

Safetyforuseinpregnancyandduringlactationhasnotbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Localirritationordermatitismayoccur.

4.9Overdose

Nonestated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

PharmacotherapeuticGroup:

Keratolytic.

MechanismofAction

Themechanismofsalicylicacidhasnotbeenestablished.

PharmacodynamicEffects

Salicylateshaveanalgesic,anti-inflammatoryandantipyreticpropertiesmuchofwhichisascribedtoaninhibitionof

prostaglandinsynthesis.However,therelevantpharmacodynamiceffectofsalicylicacidforthisproductisits

“keratolytic”action.

Themechanismofthiseffecthasbeeninvestigatedinanimalsandinman,andappearstobeduetoalipidmodifying

effectinthelipidbilayersoftheskinratherthatakeratolyticaction.Itisthoughtthatthesalicylicacidincreaseslipid

structurefluiditysoallowingmoisturetopenetrateintoareassurroundingthecallous.Thisinturnleadstoapressure

buildupcausingthecalloustobepushedupwards.Ithasbeensuggestedthattheocclusivenatureoftheplaster

enhancesthiseffect.

5.2Pharmacokineticproperties

Salicylicacidcanbeabsorbedfollowingtopicalapplication.Plasmasalicylateislargelyprotein-boundandis

metabolisedbyoxidationandconjugationwithsomeexcretedunchanged.Theeliminationofsalicylatefollowsfirst

orderkineticswithahalflifeofaboutfourhoursexceptwithhighsystemicdoseswhichresultinsaturationofthe

eliminationmechanism.

5.3Preclinicalsafetydata

SalicylicacidhasalowacutetoxicitywithoralLD

valuesof480mg/kginthemouseand891mg/kgintherat.Itisa

dermalirritantbutsystemictoxicityfromapplicationof40%w/wsalicylicacidadhesivemassisextremelyunlikely

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/04/2009 CRN 2035470 page number: 3

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PolyvinylAlkylEther(LowMolecularWeight)

PolyvinylAlkylEther(HighMolecularWeight)

TitaniumDioxide

LiquidParaffin

4,4’Thio-Bis-2-Terbutyl-5-Methylphenol

RedIronOxide

BlackIronOxide

Backingmaterial

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened

3years.

Shelflifeafterfirstopeningthecontainer

6weeks.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Sachetcontents:2,4or6medicatedadhesiveplastersmountedontoasiliconebackedpaper.

Outercontainer:polypropyleneflowwraporcardboardcarton.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

6.6Specialprecautionsfordisposalandotherhandling

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/04/2009 CRN 2035470 page number: 4

7MARKETINGAUTHORISATIONHOLDER

SchollConsumerProductsLtd

Venus

1OldParkLane

TraffordPark

Manchester

M417HA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA455/6/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoflastrenewal:24June1987

Dateoflastrenewal:24June2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/04/2009 CRN 2035470 page number: 5

Similar products

Search alerts related to this product

View documents history

Share this information