DERMAMIST DRY SKIN SPRAY

Main information

  • Trade name:
  • DERMAMIST DRY SKIN SPRAY
  • Dosage:
  • 10 %w/ w
  • Pharmaceutical form:
  • Unknown
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DERMAMIST DRY SKIN SPRAY
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0943/015/001
  • Authorization date:
  • 15-09-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dermamist10%w/wDrySkinSpray

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Whitesoftparaffin10.0%w/w.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

CutaneousSpray,solution(cutaneousspray)

Acutaneousspraydeliveringwhitesoftparaffinasaclearcolourlessspraybymeansofapressurisedaerosol.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofdryskinconditionsincludingpruritus(itchinganddryness)oftheelderlyeczema,andichthyosis(dry

scalyskin).

4.2Posologyandmethodofadministration

Adults,childrenandtheelderly:

Shakebeforeuse.Batheorshowerfornotmorethantenminutes.

Patdryandapplyspraywithoutdelay.Donotsprayonface.Sprayfromadistanceofapproximately8inches.Spray

awayfromthefaceandmovethecanwhilesprayingtoachieveaverylightcoverageofthebody.Spraysparingly;

overapplicationmaycausetheskintofeeloily.

4.3Contraindications

Hypersensitivitytoanyoftheingredients.

4.4Specialwarningsandprecautionsforuse

Forexternaluseonly.

Keepoutofreachofchildren.

Donotsprayonface.

Useinaventilatedarea.

Avoidinhalation.

Guardagainstslipping.

Discontinueuseiftheconditionismadeworse.

Donotapplytobrokenskin.

Patientsbeingdispensedortreatedwithlargequantities(>100g)ofanyparaffinbasedproductshoudlbeadvisedto

regularlychangeclothingorbeddingimpregnatedwiththeproductandkeepawayfromnakedflamesasthereisafire

hazard.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 03/03/2011 CRN 2096542 page number: 1

None.

4.6Fertility,pregnancyandlactation

Canbeused.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Notrelevant.

4.9Overdose

None.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Emollientsarefatsoroilsusedfortheirlocalactionontheskinand,occasionally,themucousmembranes.These

oleaginoussubstances,alsoknownasocclusiveagentsandhumectants,areemployedasprotectivesandasagentsfor

softeningtheskinandrenderingitmorepliable.Whitesoftparaffinformsaneffectiveocclusivelipidfilm.The

mechanismofactionisbyoccludingwaterlossfromtheouterlayerofskin.

5.2Pharmacokineticproperties

Whitesoftparaffinexertsitsphysiologicaleffectsbyforminganocclusivelayeronthesurfaceoftheskin.Itis

effectivebecauseitisnotsubjecttoabsorptionorsubsequentdistributioninthebody,excretionormetabolism.

Pharmacokineticparticularsarenotappropriateinthesecircumstances.

5.3Preclinicalsafetydata

Norelevantpre-clinicaldatahasbeengenerated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Liquidparaffin

Mediumchaintriglycerides

Butane40(butane:isobutane:propane)

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 03/03/2011 CRN 2096542 page number: 2

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Extremelyflammable.

Protectfromsunlightanddonotexposetotemperaturesexceeding50°C.

Donotpierceorburnevenwhenempty.

Donotsprayonanakedflameoranyincandescentmaterial.

Keepawayfromsourcesofignition-nosmoking.

6.5Natureandcontentsofcontainer

Pressurisedaluminiumaerosolcan.Packsizes50ml,75ml,100ml,125ml,150ml,200ml,250ml,300ml,400ml,and

500ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AlliancePharmaceuticalsLimited

BathRoad

Chippenham

WiltshireSN152BB

England

8MARKETINGAUTHORISATIONNUMBER

PA943/15/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:04April1997

Dateoflastrenewal:04April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 03/03/2011 CRN 2096542 page number: 3