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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: 02/12/2010
SPC Dermol 500 Lotion

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 02/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.1 (List of excipients) there is a change of name from "cetomacrogol 1000" to "macrogol cetostearyl ether (cetomacrogol)"

In section 10 (date of revision of the text) the date has changed to "November 2010"
Updated on 05/05/2010 and displayed until 02/12/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   01-Mar-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 2 (Qualitative and Quantitative Composition) the following text has been added: "Excipient : Cetostearyl Alcohol 5.0% w/w"

In section 5.1 (Pharmacodynamic properties) the following text has been added "ATC Code : D02 AX, emollients and protectives"

In section 6.6 (Special precautions for disposal and other handling) the text has changed to "No special requirements"

In section 9 (Renewal of the Authorisation) the date has changed to "23 June 2009"

In section 10 (Date of revision of the text) the date has changed to "March 2010"
Updated on 29/07/2009 and displayed until 05/05/2010
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 9 (Renewal of the Authorisation) the date has changed to "1 October 2007"
Updated on 11/03/2009 and displayed until 29/07/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precautions for use) : the following text has been added "The excipient cetostearyl alcohol may on rare occasions give rise to local skin reactions (e.g. contact dermatitis) in sensitive people."

In section 4.8 (Undesirable effects) : the following text has been added "These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergice in nature.  Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area."

In section 10 (Date of revision of the text) : the date has changed to "February 2009"
Updated on 11/09/2007 and displayed until 11/03/2009
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   GSL/P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4 - Special precautions for storage - Additional text added 'Replace cap after use'
 
Section 10 - Date of revision of the text - Date changed to 'November 2002'
Updated on 08/09/2004 and displayed until 11/09/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/08/2004 and displayed until 08/09/2004
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 10 (date of (partial) revision of the text
Updated on 19/07/2001 and displayed until 17/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 13/03/2001 and displayed until 19/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 15/08/2000 and displayed until 13/03/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 15/08/2000
Reasons for adding or updating:
  • No reasons supplied