BENADRYL SKIN ALLERGY RELIEF LOTION

Main information

  • Trade name:
  • BENADRYL SKIN ALLERGY RELIEF LOTION
  • Dosage:
  • 1/8/0.1%w/
  • Pharmaceutical form:
  • Cutaneous Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENADRYL SKIN ALLERGY RELIEF LOTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0823/016/002
  • Authorization date:
  • 01-04-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0823/016/002

CaseNo:2050321

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

McNeilHealthcare(Ireland)Ltd

AirtonRoad,Tallaght,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BenadrylSkinAllergyReliefLotion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom21/05/2008until31/03/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/05/2008 CRN 2050321 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BenadrylSkinAllergyReliefLotion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BenadrylSkinAllergyReliefLotioncontains:

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cutaneousliquid

Asmooth,pinkviscouscutaneousliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BenadrylSkinAllergyReliefLotionisindicatedinthetopicaltreatmentofskinmanifestationsofallergy(e.g.,

urticariaandhives),andforthereliefofirritationassociatedwithshingles,sunburn,pricklyheatandotherminorskin

affections.

4.2Posologyandmethodofadministration

Adults:

Topical.BenadrylSkinAllergyReliefLotionmaybeappliedtoaffectedparts,threetofourtimesdaily.

ChildrenandInfants:

Topical.Asforadults.

TheElderly:

Topical.Asforadults.

4.3Contraindications

Donotuseonchickenpoxormeaslesorexudativedermatoses,unlesssupervisedbyadoctor.

Donotuseonextensiveareasoftheskinexceptasdirectedbyadoctor.

Donotuseanyotherdrugscontainingdiphenhydraminewhilstusingthisproduct.

4.4Specialwarningsandprecautionsforuse

BenadrylSkinAllergyReliefLotionshouldnotbeappliedtoraw,orbrokensurfacesormucousmembranesasthis

mayresultinpercutaneousabsorptiongivingrisetosystemiceffects.Avoidcontactwiththeeyes.Ifaburning

Diphenhydraminehydrochloride1 %w/v

Zincoxide 8 %w/v

Irish Medicines Board

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washingwithsoapandwater.

Thepacklabellingcontainsthefollowingwarnings:

Donotapplytorawsurfaces.

Ifaburningsensationorrashdevelops,orifsymptomspersist,consultthedoctor.

Donotuseonchickenpox,measlesorlargeareasofskinunlessdirectedbyadoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

ThesafetyofBenadrylSkinAllergyReliefLotioninpregnancyandlactationhasnotbeenestablished.Likeany

medicine,BenadrylSkinAllergyReliefLotionshouldonlybeusedifthepossiblebenefitsoutweighthepotentialrisks

involved.Diphenhydramineisknowntobeabsorbedthroughtheskin.Diphenhydraminecrossestheplacentalbarrier

andissecretedinbreastmilk.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Rarely,skinsensitization,eczematousreactionsandphotosensitivityhavebeenreportedaftertopicalapplicationof

antihistamines.Ifthisoccurs,treatmentshouldbediscontinued.

4.9Overdose

Symptomsandsigns

AccidentalingestionorexcessiveabsorptionofBenadrylSkinAllergyReliefLotionmayleadtodose-relatedsignsof

diphenhydraminetoxicity.Theseincludedrowsinessandsedationwithanticholinergicsymptomsprevailing.Camphor

mayproducenausea,vomitinganddizziness.Athigherdoses,deliriumleadingtocoma,ataxia,increasedmuscle

reflexesandcloniformconvulsionsmayappear.

Treatment

Thestomachshouldbeemptiedbylavageandaspiration.Incasesofacutepoisoning,activatedcharcoalmaybeuseful.

Asodiumsulphatepurgativemaybegiven.Convulsionsmaybecontrolledbydiazepamorthiopentalsodium.Inthe

caseofcamphorpoisoning,lipidhaemodialysisorresinhaemoperfusionmaybeuseful.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BenadrylSkinAllergyReliefLotioncontainsdiphenhydraminehydrochloride,zincoxideandcamphor.

Diphenhydramineisapowerfulantihistamineandlocalanaesthetic(antipruritic).Inconcentrationsofbetween0.1-3.0

%,camphordepressescutaneousreceptorsandisaneffectiveanalgesic,anaestheticandantipruritic,whichprovidesa

feelingofcoolnesswhenappliedtopically.

5.2Pharmacokineticproperties

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oftheactiveingredientswillbeabsorbed.Percutaneouspenetrationofdiphenhydramineandcamphorhasbeen

demonstratedduringinappropriateuseofthesecompoundsseparately,buthasnotbeenquantified.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ferricoxidered(E172)

Ferricoxideyellow(E172)

Carmellosesodium

Glycerol

Perfumeoilsoleil78087

Hydrochloride

PurifiedWater

6.2Incompatibilities

Noneknown.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

Storeinoriginalpackage.

6.5Natureandcontentsofcontainer

BenadrylSkinAllergyReliefLotionisstoredina125mlroundamberbottlewitha28mmroll-on-pilfer-proof

(ROPP)aluminiumcaporwitha3pieceplasticchildresistant,tamperevidentclosurefittedwithapolyesterfaced

wad.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

McNeilHealthcare(Ireland)Ltd

AirtonRoad

Tallaght

Irish Medicines Board

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8MARKETINGAUTHORISATIONNUMBER

PA823/16/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1979

Dateoflastrenewal:01April2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 22/05/2008 CRN 2050321 page number: 5