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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ascabiol Emulsion 25 % w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzyl Benzoate 25 % w/v.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
A cutaneous emulsion
A homogeneous white emulsion with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of scabies and pediculosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SCABIES:
After total bathing ‘Ascabiol’ emulsion should be applied to the whole body except the head and face. A
second application may be repeated within 5 days or alternatively it may be applied on three occasions at 12 hourly
intervals.
PEDICULOSIS:
The affected region should be coated with ‘Ascabiol’ emulsion followed by a wash 24 hours later. This
may be repeated two or three times in severe cases.
For use in children the emulsion should be diluted with an equal volume of water. For infants the proportion of
emulsion to water should be 1:3.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to benzyl benzoate.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Benzyl benzoate must not be allowed to come into contact with the eyes.
‘Ascabiol’ causes little skin irritation, but may cause a transient burning sensation. This is usually mild, but can
occasionally be severe in sensitive individuals. In the event of a severe skin reaction the preparation should be washed
off using soap and water.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
If this preparation is accidentally taken by mouth, treatment should consist of gastric lavage or the administration of an
emetic. An anticonvulsant should be given as necessary, otherwise treatment is symptomatic.
IRISH MEDICINES BOARD
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