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Stiefel Ireland
GlaxoSmithKline (Ireland) Ltd, Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 16/03/2012
SPC Oilatum Shower Gel 70% w/w Gel

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 16/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   05-Mar-2012
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


The new SPC includes changes to section ‘6.5 Nature and Contents of Container’ where a new pack size range of laminate tubes has been added as a result of product transfer from Sligo to Barnard Castle.
Updated on 03/11/2011 and displayed until 16/03/2012
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   24-Oct-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



 


1.         NAME OF THE MEDICINAL PRODUCT

 

Oilatum Shower Gel 70% w/w Gel

4.1       Therapeutic Indications

 

Oilatum Shower Gel is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions.

 

4.2       Posology and Method of Administration

 

Oilatum Shower Gel may be used as frequently as necessary.  Oilatum Shower Gel should always be applied to wet skin, normally as a shower gel.

 

Shower as usual.  Apply Oilatum Shower Gel liberally to wet skin and massage gently.  Rinse briefly and lightly pat the skin dry.

4.4       Special Warnings and Precautions for Use

 

Use care to avoid slipping in the shower.  Oilatum Shower Gel should not be used on

4.6       Fertility, pregnancy and Lactation

 

There is no evidence to confirm the safety of Oilatum Shower Gel in human pregnancy and lactation; however, topical preparations containing light liquid paraffin have been in widespread use for many years without apparent ill effects.
Updated on 18/08/2011 and displayed until 03/11/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   03-Dec-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
 Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).
Updated on 15/08/2009 and displayed until 18/08/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
In section 7, the address of the Marketing Authorisation Holder has been changed.

In section10, the date of approval has been updated.
Updated on 29/10/2008 and displayed until 15/08/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 2
Change from 'Light Liquid Paraffin BP 70.00% w/w' to 'Each gram of gel contains 700mg light liquid paraffin equivalent to 70% w/w. For full list of excipients, see section 6.1.'
 
Section 3
From 'A Shower gel for topical application to wet skin' to 'Gel. White, translucent, oily gel with an odour of perfume'.
 
Section 6.1
Change of excipients
 
Section 6.2
From 'None' to 'Not applicable'
 
Section 6.3
From 'Three' to '3'
 
Section 6.4
From 'Do not store above 25degreesC' to 'Store below 25degreesC'

Section 6.5
Addition of 'Not all pack sizes may be marketed'
 
Section 6.6
From 'There are no special instructions for use or handling of Oilatum Gel' to 'No special requirements'
 
Section 9
Change of date
 
Section 10
Addition of date
Updated on 01/09/2006 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   08/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 2 Qualitative and Quantitative Composition - format updated to Light Liquid Paraffin BP 70.00% w/w
 
Section 4.6 Pregnancy and lactation - wording updated to say 'ill effects' not 'ill consequence'.
 
Section 7 Address of MA holder is UK, not England.
Updated on 16/08/2005 and displayed until 01/09/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Light Liquid Paraffin