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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Braunoderm Coloured Isopropyl Alcohol 500 mg/g and Iodinated Povidone 10 mg/g Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients:
100.0 g solution contains:
50.0 g Isopropyl Alcohol
1.0 g Iodinated Povidone, with a content of 10 % available iodine
Excipients:
Sunset Yellow (E110) 0.075% w/w
Ponceau 4R (E124) 0.05% w/w
Brilliant Black BN (E151) 0.0015% w/w
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
Clear, brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic for disinfection of intact skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply undiluted Braunoderm coloured to the skin area to be disinfected and spread with sterile swab. Wet the skin to
be treated completely and then let dry.
4.3 CONTRAINDICATIONS
Use in patients with hypersensitivity to iodine or the other excipients.
Before and after radio-iodine-therapy (until complete healing).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should evidence of local irritation or sensitivity occur, use of the product should cease. If no improvement occurs, the
doctor should be consulted.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Iodine reacts with mercury compounds forming strongly caustic mercurous iodide.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/01/2007_
_CRN 2031802_
_page number: 1_
4.6 PREGNANCY AND LACTATION
Care must be taken in the case of pregnant women and infants up to the age of 6 months, as well as patients suffering
from noninfected nodular strumae or latent hyperthyreosis.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE
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