FREEZONE

Main information

  • Trade name:
  • FREEZONE Cutaneous Solution 17.0 %w/w
  • Dosage:
  • 17.0 %w/w
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FREEZONE Cutaneous Solution 17.0 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/014/001
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FreezoneLiquidCornRemover

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Theliquidcontains17.00%w/wofsalicylicacidinaformulationasdescribedintheapplication.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

CutaneousLiquid

Orange/yellowviscousliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asakeratolyticfortreatmentofcorns.

4.2Posologyandmethodofadministration

Adultsandchildrenovertheageofsixyears:Soaktheaffectedfootinwarmwaterfor15minutes.Drythoroughly

andrubthecornverygentlywithapumicestoretoremoveanydeadskin.ApplyFreezoneadropatatimeuntilthe

corniscovered.

Applytwicedailyfor2-3days.Repeatifnecessary.

4.3Contraindications

Nonestated.

4.4Specialwarningsandprecautionsforuse

Ifthereisdoubtastothediagnosis,consultthedoctor.

Avoidcontactwitheyes,mouthormucousmembranes.

Ifthereisnoimprovementoraggravationoftheconditions,thedoctorshouldbeconsulted.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Irish Medicines Board

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Date Printed 18/08/2006 CRN 2026939 page number: 1

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Nonestated.

4.9Overdose

Immediatemedicaladviceshouldbesoughtintheeventofoverdosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nonestated.

5.2Pharmacokineticproperties

Nonestated.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Acetone

IndustrialMethylatedSpirits99%

Pyroxylin(NitroCelluloseDHM10/25)

CastorOil

SunsetYellow(E110)

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeisfiveyearsfromthedateofmanufacture.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Irish Medicines Board

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Date Printed 18/08/2006 CRN 2026939 page number: 2

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

WhitehallLaboratories

HuntercombeLaneSouth

Taplow

Maidenhead

BerksSL6OPH

England

8MARKETINGAUTHORISATIONNUMBER

PA172/14/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 18/08/2006 CRN 2026939 page number: 3