DERMIDEX

Main information

  • Trade name:
  • DERMIDEX Cream 1.2/0.5/0. %w/w
  • Dosage:
  • 1.2/0.5/0. %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DERMIDEX Cream 1.2/0.5/0. %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0610/002/001
  • Authorization date:
  • 19-08-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DermidexDermatologicalCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Cream

Smoothwhitehomogenouscreamwithacharacteristicperfume.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Antiseptic,anaesthetic,anti-irritantandemollientagent.Forthetreatmentofmildpaincausedbyminorskincuts,

scratchesandgrazes(chapping)andsorenesscausedbydetergents,soaps,deodorantsandjewelleryandbitesand

stings.

4.2Posologyandmethodofadminstration

Adults,theelderlyandchildrenover4years

Applytotheaffectedareaeverythreehours.

Notsuitableforchildrenunderfouryearsofage.

4.3Contraindications

Knownsensitivitytotheactiveconstituents.

4.4Specialwarningsandprecautionsforuse

Forexternaluseonly.Keepoutofthereachofchildren.Theproductshouldnotbeusedforlongerthansevendays

withoutseekingmedicaladvice.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Lidocaine 1.20%w/w

Aluminiumchlorhydroxyallantoinate 0.25%w/w

Chlorobutanolhemihydrate 1.00%w/w

Cetrimide 0.50%w/w

Irish Medicines Board

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Date Printed 16/05/2006 CRN 2023335 page number: 1

4.6Pregnancyandlactation

Noeffectsknowninpregnancyandlactation.Howeveraswithallmedicinesusewithcaution.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Occasionallytherehavebeenreportsofskinreactionswithallsuchpreparations.

4.9Overdose

Overdoseisunlikely.Iflargeamountsareingested,gastriclavageandsupportivetherapymaybeindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notapplicable.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Cetylalcohol

Glycerylmonostearate

Isopropylmyristate

Lightliquidparaffin

Phenoxyethanol

Sorbitolsolution70%(non-crystallising)

Stearylalcohol

Perfumesport11412C

Purifiedwater

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Irish Medicines Board

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Date Printed 16/05/2006 CRN 2023335 page number: 2

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

3g,4g,5g,7.5g,10g,30gor50gorproductcontainedin:

Lacqueredconvextubewithalowormediumdensitypolyethylenecapinacarton.

Aluminiumtubeswithapolyamideinternallacquer,amembranenozzlefittedwithfullspikedwhitepolyethylene

capinacarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Thornton&RossLimited

Linthwaite

HuddersfieldHD75QH

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA610/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27November1991

Dateoflastrenewal:19August2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 16/05/2006 CRN 2023335 page number: 3