BENADRYL SKIN ALLERGY RELIEF 1/8/0.1%w/ %w/w Cream

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE ZINC OXIDE CAMPHOR
Available from:
McNeil Healthcare (Ireland) Ltd
INN (International Name):
DIPHENHYDRAMINE HYDROCHLORIDE ZINC OXIDE CAMPHOR
Dosage:
1/8/0.1%w/ %w/w
Pharmaceutical form:
Cream
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization number:
PA0823/016/001
Authorization date:
2012-07-17

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BenadrylSkinAllergyReliefCream

Diphenhydraminehydrochloride1.0%w/w

ZincOxide8.0%w/w

RacemicCamphor0.1%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BenadrylSkinAllergyReliefCreamcontains:

Thecreamalsocontains:

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

Asmooth,pinkcream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BenadrylSkinAllergyReliefCreamisindicatedinthetopicaltreatmentofskinmanifestationsofallergy(e.g.,

urticariaandhives),andforthereliefofirritationassociatedwithshingles,sunburn,pricklyheatandotherminorskin

affections.

4.2Posologyandmethodofadministration

Adults:

Topical.BenadrylSkinAllergyReliefCreammaybeappliedtoaffectedparts,threetofourtimesdaily.

ChildrenandInfants:

Topical.Asforadults.

TheElderly:

Diphenhydraminehydrochloride 1 %w/w

Zincoxide 8 %w/w

Racemiccamphor 0.1 %w/w

CetostearylAlcohol 8.9%w/w

PropylParahydroxybenzoate(E216) 0.2%w/w

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/02/2012 CRN 2111836 page number: 1

4.3Contraindications

Donotuseonchickenpoxormeaslesorexudativedermatoses,unlesssupervisedbyadoctor.

Donotuseonextensiveareasoftheskinexceptasdirectedbyadoctor.

Donotuseanyotherdrugscontainingdiphenhydraminewhilstusingthisproduct.

4.4Specialwarningsandprecautionsforuse

BenadrylSkinAllergyReliefCreamshouldnotbeappliedtoraw,orbrokensurfacesormucousmembranesasthis

mayresultinpercutaneousabsorptiongivingrisetosystemiceffects.Avoidcontactwiththeeyes.Ifaburning

sensationorrashdevelopsoriftheconditionpersists,treatmentshouldbediscontinued.Ifnecessaryremoveby

washingwithsoapandwater.

Thepacklabellingcontainsthefollowingwarnings:

Donotapplytorawsurfaces.

Ifaburningsensationorrashdevelops,orifsymptomspersist,consultthedoctor.

Donotuseonchickenpox,measlesorlargeareasofskinunlessdirectedbyadoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

ThesafetyofBenadrylSkinAllergyReliefCreaminpregnancyandlactationhasnotbeenestablished.Likeany

medicine,BenadrylSkinAllergyReliefCreamshouldonlybeusedifthepossiblebenefitsoutweighthepotentialrisks

involved.Diphenhydramineisknowntobeabsorbedthroughtheskin.Diphenhydraminecrossestheplacentalbarrier

andissecretedinbreastmilk.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Rarely,skinsensitization,eczematousreactionsandphotosensitivityhavebeenreportedaftertopicalapplicationof

antihistamines.Ifthisoccurs,treatmentshouldbediscontinued.

4.9Overdose

Symptomsandsigns

AccidentalingestionorexcessiveabsorptionofBenadrylSkinAllergyReliefCreammayleadtodose-relatedsignsof

diphenhydraminetoxicity.Theseincludedrowsinessandsedationwithanticholinergicsymptomsprevailing.Camphor

mayproducenausea,vomitinganddizziness.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/02/2012 CRN 2111836 page number: 2

Treatment

Thestomachshouldbeemptiedbylavageandaspiration.Incasesofacutepoisoning,activatedcharcoalmaybeuseful.

Asodiumsulphatepurgativemaybegiven.Convulsionsmaybecontrolledbydiazepamorthiopentalsodium.Inthe

caseofcamphorpoisoning,lipidhaemodialysisorresinhaemoperfusionmaybeuseful.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BenadrylSkinAllergyReliefCreamcontainsdiphenhydraminehydrochloride,zincoxideandcamphor.

Diphenhydramineisapowerfulantihistamineandlocalanaesthetic(antipruritic).Inconcentrationsofbetween0.1-3.0

%,camphordepressescutaneousreceptorsandisaneffectiveanalgesic,anaestheticandantipruritic,whichprovidesa

feelingofcoolnesswhenappliedtopically.

5.2Pharmacokineticproperties

BenadrylSkinAllergyReliefCreamisintendedonlyfortopicalapplicationtotheskin.Attherecommendeddoselittle

oftheactiveingredientswillbeabsorbed.Percutaneouspenetrationofdiphenhydramineandcamphorhasbeen

demonstratedduringinappropriateuseofthesecompoundsseparately,buthasnotbeenquantified.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ferricoxidered(E172)

Ferricoxideyellow(E172)

Whiteceresin

Cetostearylalcohol

Perfumeoilsoleil78087

Sorbitanstearate

PropylParahydroxybenzoate(E216)

Propyleneglycol

Polysorbate60

Purifiedwater

6.2Incompatibilities

Notapplicable

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/02/2012 CRN 2111836 page number: 3

6.5Natureandcontentsofcontainer

BenadrylSkinAllergyReliefCreamisstoredina42gepoxyphenolic-basedlacqueredaluminiumtube.

Tubesareclosedbyawhitespikedscrewcapmadeofpolypropylene.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

McNeilHealthcare(Ireland)Ltd

AirtonRoad

Tallaght

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA823/16/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1979

Dateoflastrenewal:01April2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/02/2012 CRN 2111836 page number: 4

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