Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MALATHION
Seton Products Ltd
0.5%w/v %w/v
Cutaneous Emulsion
1993-07-13
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 Topical. ADULTS INCLUDING THE ELDERLY AND CHILDREN OVER 6 MONTHS OF AGE: 1. Apply thoroughly to all parts of the hair and scalp or the hair of the affected areas. Leave for at least one hour on body or preferably overnight on scalp and before bathing. Treatment should be repeated after 7 days. 2. Apply liquid to entire body surface except scalp. Children under the age of two years should have a thin film of the liquid applied to the scalp, face and ears, avoiding the eyes and mouth. Treatment should be repeated after 7 days. This product should not be used on infants less than 6 months of age except under medical supervision. 4.3 CONTRAINDICATIONS 1. Known hypersensitivity to active constituents. 2. Not to be used on infants less than six months old except on medical advice. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. The eyes should be well protected during the application and washing of hair. 2. Persons applying this product should wear rubber gloves so that their continued direct contact is avoided. 3. All members of the household of the patients should be treated, preferably simultaneously. IRISH MEDICINES BOARD _______________________ Read the complete document