BENZOYL PEROXIDE

Main information

  • Trade name:
  • BENZOYL PEROXIDE
  • Dosage:
  • 10% %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENZOYL PEROXIDE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1155/007/002
  • Authorization date:
  • 24-06-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BenzoylPeroxideCream10%

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BenzoylPeroxide10%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cream

Creamy,whitethixotropiccream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AcneVulgaris.

4.2Posologyandmethodofadministration

Fortopicaluseonly.

Adults,childrenandtheelderly:

Bygentlemassageoveralltheaffectedareatwoorthreetimesdaily.

4.3Contraindications

AcneRosacea.PatientswithknownsensitivitytoBenzoylPeroxide.

4.4Specialwarningsandprecautionsforuse

Contactwithmouthandeyesshouldbeavoided.Careshouldbetakentoavoidcontactwith

dyedfabricsasthisproductmayadverselyaffectdye-fastness.

Individualsmaynoticedryskin.

Inafewisolatedcases,overreactiontoBenzoylPeroxideCream10%mayoccur.Tominimisethispossibility,

selectasmallareaofskinbehindtheear,applythecreamandleavefortwelvehours.Ifsevereirritationorredness

occurs,donotproceedwiththetreatment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

BenzoylPeroxideisanoxidisingagent.Hence,BenzoylPeroxideCream10%shouldnotbeusedatthesametime

Irish Medicines Board

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Date Printed 20/07/2006 CRN 2025728 page number: 1

4.6Pregnancyandlactation

BenzoylPeroxideCream10%isnotcontra-indicatedinpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Ifsymptomspersistoriftheconditionworsensorifirritation,itchorrashoccurs,treatment

shouldbediscontinuedandthephysicianorpharmacistconsultedforadvice.

4.9Overdose

Ifaccidentallyingestedsymptomaticandsupportivemanagementisadvised.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BenzoylPeroxideisamildkeratolyticagentandalsohasantisepticproperties.Ithasalocaleffectonlyandisnot

absorbedbytheskin.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Whitesoftparaffin

EmulgadeF(consistingofCetostearylalcohol,SodiumcetostearylsulphateandPEG–40Castoroil)

Edeticacid

Sodiumdihydrogenphosphatedihydrate

Lacticacid

Maizestarch

Purifiedwater

6.2Incompatibilities

Anytopicalagentthatwouldreactwithanoxidisingagent.

6.3ShelfLife

Irish Medicines Board

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Heat-sealed,low-densitypolyethylenetubeswithaflush-fittingpolypropylenecapcontaining50gofproduct.Each

tubeiscartonedandcontainsapackageinsert.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Gentlymassageoveralltheaffectedareatwoorthreetimesdaily.

7MARKETINGAUTHORISATIONHOLDER

FerndalePharmaceuticalsLtd

12YorkPlace

LeedsLS12DS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1155/7/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:6November1987

Dateoflastrenewal:6November2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 20/07/2006 CRN 2025728 page number: 3