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Dermal Laboratories Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
Telephone: +44 (0)1462 458 866
Fax: +44 (0)1462 420 565
WWW: http://www.dermal.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 06/08/2010
SPC Exterol 5% w/w Ear Drops, Solution

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

Updated on 06/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.3 (Shelf life) the following text has been added: "Discard 4 weeks after first opening."

In section 10 (Date of revision of the text) the date has changed to "July 2010."
Updated on 29/11/2007 and displayed until 06/08/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - Name of the medicinal product: Name changed to 'Exterol 5% w/w Ear Drops, Solution'
 
Section 3 - Pharmaceutical Form: Text added 'Ear drops, solution'
 
Section 10 - Date of revision of the text: Date changed to 'September 2007'
Updated on 11/09/2007 and displayed until 29/11/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Special warnings and precautions for use - Addition of text ' Replace cap after use, and return bottle to carton'
 
Section 6.4 - Special precautions for storage - Addition of text 'Store upright' and removal of text ' ... and store bottle upright in carton'
 
Section 9 - Renewal of the Authorisation - Date changed to '10 January 2007'
 
Section 10 - Date of revision of the text - Date changed to 'January 2007'
Updated on 07/09/2004 and displayed until 11/09/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/08/2004 and displayed until 07/09/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 24/09/2003 and displayed until 03/08/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 17/09/2002 and displayed until 24/09/2003
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/07/2001 and displayed until 17/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 18/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  urea hydrogen peroxide