BRUSH-OFF COLD SORE TREATMENT 10%w/v %w/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

POVIDONE-IODINE

Available from:

Seton Healthcare Group PLC

INN (International Name):

POVIDONE-IODINE

Dosage:

10%w/v %w/v

Pharmaceutical form:

Cutaneous Solution

Authorization status:

Withdrawn

Authorization date:

2006-07-07

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brush-Off Cold Sore Treatment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone Iodine 10% w/v
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous solution
A clear, reddish brown, alcoholic/aqueous solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic in the prevention and
treatment of topical cutaneous infections.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For topical administration.
Use once or twice daily or as directed.
Apply directly to the affected area and allow to dry. Cover with
a dressing if desired.
4.3 CONTRAINDICATIONS
1. 
Use in patients with a known or suspected hypersensitivity to
iodine.
2. 
Regular use in patients and users with thyroid disorders (in
particular nodular colloid goitre, endemic goitre and 
Hashimoto’s thyroiditis).
3. 
Do not use on children under 2 years of age.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
1. 
If symptoms persist, consult your doctor.
2. 
Side effects include local irritation and hypersensitivity.
3. 
The product should not be used near the eyes.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
1. 
Absorption of iodine from povidone iodine through
either intact or damaged skin may interfere with thyroid 
function tests.
2. 
Contamination with
povidone iodine of several types of tests for the detection
of occult blood in faeces or blood 
in urine may produce false positive results.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 24/10/2005_
_CRN 2016059_
_page number: 1_
4.6 PREGNANCY AND LACTATION
Regular use of povidone iodine should be avoided in
pregnant or lactating women as absorbed iodine can cross the 
placental barrier and be secre
                                
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