Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LIDOCAINE CETRIMONIUM BROMIDE ALCLOXA CHLOROBUTANOL
Thornton & Ross Limited
1.2/0.5/0. %w/w
Cream
2002-08-19
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dermidex Dermatological Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Cream Smooth white homogenous cream with a characteristic perfume. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiseptic, anaesthetic, anti-irritant and emollient agent. For the treatment of mild pain caused by minor skin cuts, scratches and grazes (chapping) and soreness caused by detergents, soaps, deodorants and jewellery and bites and stings. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Adults, the elderly and children over 4 years Apply to the affected area every three hours. Not suitable for children under four years of age. 4.3 CONTRAINDICATIONS Known sensitivity to the active constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Keep out of the reach of children. The product should not be used for longer than seven days without seeking medical advice. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. Lidocaine 1.20 % w/w Aluminium chlorhydroxyallantoinate 0.25 % w/w Chlorobutanol hemihydrate 1.00 % w/w Cetrimide 0.50 % w/w For excipients, see 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/05/2006_ _CRN 2023335_ _page number: 1_ 4.6 PREGNANCY AND LACTATION No effects known in pregnancy and lactation. However as with all medicines use with caution. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Occasionally there have been reports of skin reactions with all such preparations. 4.9 OVERDOSE Overdose is unlikely. If large amounts are ingested, gastric lavage and supportive therapy may be indicated. 5 PHARMACOLOGICAL PROPE Read the complete document