Aquasept Skin Cleanser 20mg/ml Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Triclosan

Available from:

Ayrton Saunders Ltd

ATC code:

D08AE; D08AE04

INN (International Name):

Triclosan

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Cutaneous solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Phenol and derivatives; triclosan

Authorization status:

Not marketed

Authorization date:

1992-04-22

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aquasept Skin Cleanser 20mg/ml Cutaneous Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20mg Triclosan
Excipients: also contains chlorocresol 0.25% w/v, and Propylene glycol
5% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A clear blue aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This product has an antibacterial effect and is intended for the
following uses:
For skin disinfection prior to surgery and for routine skin cleansing
to reduce the risk of cross-infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For pre-operative hand disinfection (100ml, 250ml, 500ml, 5l):
Wet area to be cleansed. Apply about 5ml of Aquasept and wash for one
minute, paying particular attention to the area
around the fingernails and cuticles and between the fingers. Rinse and
repeat for two minutes. Rinse thoroughly and dry
hands with a sterile towel.
Antiseptic skin cleanser (100ml, 250ml, 500ml, 5l):
Wet area to be cleansed and use Aquasept as a liquid soap, washing
thoroughly for one minute. Rinse and dry
thoroughly.
4.3 CONTRAINDICATIONS
Hypersensitivity to triclosan or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Avoid contact with eyes or mucous membranes.
Keep out of reach of children.
Do not apply to broken skin.
Some product excipients may give rise to allergic reactions in some
people.
In this instance, discontinue use and seek
medical advice.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None stated.
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