DERBAC-M LIQUID 0.5%w/v %w/v Cutaneous Emulsion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
MALATHION
Available from:
SSL International plc
INN (International Name):
MALATHION
Dosage:
0.5%w/v %w/v
Pharmaceutical form:
Cutaneous Emulsion
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Derbac M Liquid 0.5% w/w Cutaneous emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The liquid contains 0.5% w/w Malathion.
Also contains methyl parahydroxybenzoate (E218) 0.20% w/w and propyl parahydroxybenzoate (E216) 0.08% w/w.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Emulsion.
Creamy white perfumed emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. For the treatment of severe infestation of the scalp or pubic with lice (T. Pediculosis).
2. For the treatment of scabies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical external use only
_ADULTS, THE ELDERLY AND CHILDREN AGED 6 MONTHS AND OVER:_
As this product does not contain alcohol, it may be more suitable for those with asthma or eczema.
_TREATMENT OF HEAD LICE_
Rub the liquid into the scalp until all the hair and scalp is thoroughly moistened. Leave the hair to dry naturally in a
warm but well ventilated room. After 12 hours, or the next day if preferred, shampoo the hair in the normal way.
Rinse the hair and comb whilst wet to remove dead lice and eggs (nits) using the Nit Comb.
Treatment should be repeated after 7 days.
_TREATMENT OF CRAB (PUBIC) LICE_
Apply Derbac-M Liquid to the entire skin surface. Pay particular attention to all hairy areas including beards and
moustaches. Avoid any other areas above the neck. Leave on for at least one hour before washing but preferably
Derbac-M Liquid should be left on overnight. Wash off in the usual manner.
Treatment should be repeated after 7 days.
_TREATMENT OF SCABIES_
Apply Derbac-M Liquid to the entire skin surface. In adults it may not be necessary to apply above the neck but
children under the age of two years should have a t
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