AYRTONS ANTISEPTIC OINTMENT

Main information

  • Trade name:
  • AYRTONS ANTISEPTIC OINTMENT
  • Dosage:
  • 5/0.5 %w/w
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AYRTONS ANTISEPTIC OINTMENT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0501/001/001
  • Authorization date:
  • 26-11-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AyrtonsAntisepticOintmentZincOxide5.0%w/w&DichlorobenzylAlcohol0.5%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Ointment

Smooth,soft,homogenous,pinkointmentwithafaintsmellofmethylsalicylate.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AyrtonsAntisepticOintmentisanointmentforthetreatmentandreliefofcuts,sores,burns,wounds,roughand

chappedskin.

4.2Posologyandmethodofadministration

Byexternalapplication.

Applytoaffectedparts.

4.3Contraindications

Woolfatmaycauselocalskinreactions(e.g.contactdermatitis).

4.4Specialwarningsandprecautionsforuse

Forexternaluseonly.

Keepoutofreachandsightofchildren.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Zincoxide 5.0%w/w

Dichlorobenzylalcohol 0.5%w/w

Excipients:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030867 page number: 1

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Nonestated.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ZincOxidehasamildastringentactionontheskinandactsasasoothingandprotectiveapplication.

DichlorobenzylAlcohol(MyacideSP)isanantisepticandathigherusedconcentrations(0.5%)hasfastbroad

anti-microbialaction.Itisnon-irritantevenuptolevelsof2.5%inointmentformulation.

5.2Pharmacokineticproperties

Nonestated.

5.3Preclinicalsafetydata

Thisproducthasbeenusedoveralongperiodoftimewithnoadversesideeffectsreported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Woolfat

Methylsalicylate

Terpineol

Pigmentcertolakeponceau4R(E124)

Yellowsoftparaffin

Whitebeeswax

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

Irish Medicines Board

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Date Printed 06/12/2006 CRN 2030867 page number: 2

6.5Natureandcontentsofcontainer

Polypropylenecontainer/lid-30gor500g.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AyrtonSaundersLtd.

10SpindusRoad

SpekeHallIndustrialEstate

Speke

LiverpoolL241YA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA501/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26November1991

Dateoflastrenewal:26November2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030867 page number: 3