CORN REMOVAL PADS

Main information

  • Trade name:
  • CORN REMOVAL PADS
  • Dosage:
  • 40.0 %w/ w
  • Pharmaceutical form:
  • Impregnated Dressing
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CORN REMOVAL PADS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0455/006/001
  • Authorization date:
  • 24-06-1987
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CornRemovalPads

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Medicatedplaster

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofcorns.

4.2Posologyandmethodofadministration

Adults

Forthebestresultsthefeetshouldbewashedanddriedbeforeuse.Onemedicateddiscshouldbeplacedonthecorn,

coveredwithaplaster.Thisshouldberepeateddailyuntilthecorncanberemoved.Treatmentshouldnotcontinuefor

morethantwoweeks.

Nodistinctionismadebetweendifferentcategoriesofpatient.

Children

Notrecommendedforchildrenunder16yearsofage,exceptfollowingadoctor’srecommendation.

4.3Contraindications

Nottobeusedbydiabeticsorthosewithseverecirculatorydisorders,exceptfollowingadoctor’spermissionand

recommendation.

Nottobeusedbythosesensitivetosalicylicacidoranyoftheotherconstituentsoftheproduct.

Nottobeusedifthecornorsurroundingskinisbrokenorinflamed.

4.4Specialwarningsandprecautionsforuse

Discontinueuseandremoveplasterifexcessivediscomfortisexperienced.

Donotapplytonormalskin.

Ingredient %w/w

Irish Medicines Board

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Date Printed 20/02/2007 CRN 2034004 page number: 1

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

structurefluiditysoallowingmoisturetopenetrateintoareassurroundingthecorn.Thisinturnleadstoapressure

buildupcausingthecorntobepushedupwards.Ithasbeensuggestedthattheocclusivenatureoftheplasterenhances

thiseffect.

5.2Pharmacokineticproperties

Salicylicacidcanbeabsorbedfollowingtopicalapplication.Plasmasalicylateislargelyprotein-boundandis

metabolisedbyoxidationandconjugationwithsomeexcretedunchanged.Theeliminationofsalicylatefollowsfirst

orderkineticswithahalflifeofaboutfourhoursexceptwithhighsystemicdoseswhichresultinsaturationofthe

eliminationmechanism.

5.3Preclinicalsafetydata

SalicylicacidhasalowacutetoxicitywithoralLD

valuesof480mg/kginthemouseand891mg/kgintherat.Itisa

dermalirritantbutsystemictoxicityfromapplicationof40%w/wsalicylicacidadhesivemassisextremelyunlikely

Irish Medicines Board

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Date Printed 20/02/2007 CRN 2034004 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PolyvinylAlkylEther(LowMolecularWeight)

PolyvinylAlkylEther(HighMolecularWeight)

TitaniumDioxide

LiquidParaffin

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

RedIronOxide

BlackIronOxide

BackingMaterial

6.2Incompatibilities

Notrelevant.

6.3ShelfLife

Shelf-lifeinproductscontainingthemedicatedadhesivepackagedforsale

3years.

Shelf-lifeafterfirstopeningthecontainer

6weeks.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Sachetcontents:

4,6or8medicatedadhesiveplastersmountedontoasiliconebackedpaper.

4,6or8coverplastersmountedontoasiliconebackedpaper.

Outercontainer:

polypropyleneflowwraporcardboardcarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

SchollConsumerProductsLtd

Venus

1OldParkLane

TraffordPark

Manchester

M417HA

Irish Medicines Board

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Date Printed 20/02/2007 CRN 2034004 page number: 3

8MARKETINGAUTHORISATIONNUMBER

PA455/6/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24June1987

Dateoflastrenewal:24June2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 20/02/2007 CRN 2034004 page number: 4