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Dermal Laboratories Limited

Dermal Laboratories Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR , UK
Telephone: +44 (0)1462 458 866
Fax: +44 (0)1462 420 565
Summary of Product Characteristics last updated on medicines.ie: 10/07/2007
SPC Exterol 5% w/w Ear Drops, Solution

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 10/07/2007 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 1: Text changed to "Exterol 5% w/w Ear Drops, Solution"
 
Section 2: Text added "For a full list of excipients, see section 6.1"
 
Section 3: Text changed to "Ear drops, solution. Clear, straw-coloured viscous solution" 
 
Section 6.3: Text added "Discard 4 weeks after first opening"
 
Section 6.4: Text changed to "Store upright. Do not store above 250C. Keep the bottle tightly closed. Keep the bottle in the outer carton"
 
Section 6.5: Text changed to "8 ml easy squeeze plastic dropper bottle with screw cap"
 
Section 6.6: Text changed to "No special requirements"
 
Section 9: Date changed to "28 January 2007"
 
Section 10: Date changed to "January 2007" 
Updated on 19/06/2003 and displayed until 10/07/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Urea Hydrogen Peroxide

Versions

 
10/07/2007 to Current
19/06/2003 to 10/07/2007
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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