CALAMINE B.P. 15, 5 %w/v Cutaneous Suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CALAMINE ZINC OXIDE
Available from:
Ricesteele Manufacturing Ltd
INN (International Name):
CALAMINE ZINC OXIDE
Dosage:
15, 5 %w/v
Pharmaceutical form:
Cutaneous Suspension
Authorization status:
Withdrawn
Authorization number:
PA0095/021/001
Authorization date:
2008-04-27

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CalamineLotionBP

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Calamine15%w/vandZincOxide5%w/v.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cutaneoussuspension

Pinkcutaneoussuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Calaminelotionhasmildastringentandsoothingproperties.Itisindicatedforthemanagementofminorpruritic

conditions.

4.2Posologyandmethodofadministration

Fortopicaluse.Shakebottlebeforeuse.

Applytoaffectedareathreetimesdailyasrequired.

4.3Contraindications

None.

4.4Specialwarningsandprecautionsforuse

Thisproductisforexternaluseonly.

Ifsymptomspersistorworsenconsultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

Safetyinpregnancyhasnotbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/07/2006 CRN 2025353 page number: 1

4.8Undesirableeffects

Noneknown.

4.9Overdose

NotApplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalamineLotionactslocallyontheskinandhasmildastringentandsoothingproperties.

5.2Pharmacokineticproperties

Noinformationavailable.

5.3Preclinicalsafetydata

CalamineandZincOxidearewellestablisheddrugsubstancesandhavebeenwidelyusedformanyyears.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Bentonite

SodiumCitrate

Phenol

Glycerol

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

AmberTypeIIIsodaglassbottleswithLDPEliner,unlinedPPorPPscrewcapswithawoodpulpwaddingand

aluminiumfoilcontactlayercontaining125ml,250mlor500mlofsuspension.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/07/2006 CRN 2025353 page number: 2

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakebottlebeforeuse.

7MARKETINGAUTHORISATIONHOLDER

RiceSteeleManufacturingLimited

CookstownIndustrialEstate

Tallaght

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA95/21/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27April1993

Dateoflastrenewal:27April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/07/2006 CRN 2025353 page number: 3

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