Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MALATHION
SSL International PLC
MALATHION
0.5 %w/v
Unknown
Product not subject to medical prescription
Withdrawn
2010-04-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Malathion Lotion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Malathion 0.5 % w/v. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Cutaneous solution. Clear, colourless alcoholic cutaneous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of lice infestation of scalp or body hair. For the treatment of scabies. This product is intended for treatment only and not prevention of lice and scabies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For head lice Apply to the hair, rub gently into scalp and allow to dry naturally. As all lice and eggs will have to be eliminated the hair may be shampooed after 2 hours. The hair may be fine tooth-combed before drying. For pubic lice As for lice, applying the lotion to the pubic hair and the hair between the legs and around the anus. For scabies Use cotton wool to apply lotion to all parts of the body except face and scalp, rub in well, allow to dry naturally. Do not bathe until 12 hours after treatment. 4.3 CONTRAINDICATIONS Known hypersensitivity to active constituents. 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 the 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 patient should be treated, preferably simultaneously. 4. The source of infestation should be sought and treated. 5. This product is poisonous if ingested. If accidentally swallowed, contact your local doctor or hospital immediately. 6. Prolonged continued applications should be avoided. Read the complete document