Страна: Мальта
мова: англійська
Джерело: Medicines Authority
Reckitt Benckiser Healthcare B.V. Siriusdreef 14 Hoofddorp Noord-Holland 2132 WT, Netherlands
D08AE05
CHLOROXYLENOL 4.8 % (W/V)
CONCENTRATE FOR CUTANEOUS SOLUTION
CHLOROXYLENOL 4.8 % (W/V)
OTC
ANTISEPTICS AND DISINFECTANTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-04-14
Page 1 PACKAGING LEAFLET: INFORMATION FOR THE USER DETTOL ANTISEPTIC LIQUID CHLOROXYLENOL 4.8% W/V FOR CUTANEOUS SOLUTION FOR EXTERNAL USE ONLY IMPORTANT INFORMATION ABOUT THE INGREDIENTS OF DETTOL ANTISEPTIC LIQUID CHLOROXYLENOL 4.8% W/V This product contains Chloroxylenol 4.8 w/w as the active ingredient which may cause skin irritation (concentration will be expressed as per the local agreement). This medicine contains fragrance with d-Limonene and trace amounts of Benzyl Alcohol. D- limonene and Benzyl Alcohol may cause allergic reactions. Benzyl Alcohol may cause mild local irritation. It must be diluted with water before use READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for Cutaneous Solution carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for cutaneous solution is and what it is used for 2. Before you use Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for cutaneous solution 3. How to use Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for cutaneous solution 4. Possible side effects 5. How to store Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for cutaneous solution 6. Further information 1. WHAT DETTOL ANTISEPTIC LIQUID CHLOROXYLENOL 4.8% W/V FOR CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for cutaneous solution, which after diluting in water to produce a milky solution, is a topical antiseptic used for cleansing of minor wounds such as cuts grazes and insect bites and stings. It is in a concentrated form and requires dilution before use. DO NOT USE DETTOL ANTISEPTIC LIQ Прочитайте повний документ
Page 1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v for Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chloroxylenol 4.8mg in 100mg concentrate for Cutaneous solution Excipients with known effect: Fragrances containing allergens* *Contained within pine oil For full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Concentrate for cutaneous solution. Clear, amber liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiseptic cleansing of cuts, bites, abrasions and insect bites and stings. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For Cutaneous use Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v should not be used undiluted Cuts, bites, abrasions and insect stings - wash the area with 50 ml Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v diluted to one litre (5%, 1:20) with water and cover with dry gauze or lint. Once diluted the liquid becomes a milky white, opaque solution with pine odour. Dettol Antiseptic Liquid Chloroxylenol 4.8% w/v should not be used undiluted PAEDIATRIC PATIENTS Not to be used on children under 12 months. 4.3 CONTRAINDICATIONS Known hypersensitivity to the active substance or any of the excipients Eczematous conditions. Page 2 Not to be used on children under 12 months of age. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. This product is only suitable for wound cleansing as a first aid measure and is not suitable for surgical antisepsis or use in a hospital setting. Following accidental ingestion, it is advised to consider dilution with milk or water if vomiting has not occurred. If skin or eye contamination has occurred, copious irrigation should be performed. This should be followed by a careful eye examination for corneal burns. If corneal burns are noted, ophthalmologic consultation should be obtained Do not use in or around the eyes, ears nose or mouth. If contact is made, wash thoroughly with cold water. Not for use on large areas of the body or on sensitive skin. Th Прочитайте повний документ