Страна: Мальта
мова: англійська
Джерело: Medicines Authority
CAMPHOR, HAMAMELIS VIRGINIANA, EUCALYPTUS OIL, ZINC OXIDE, METHYL SALICYLATE, MELALEUCA OIL
G. R. Lane Health Products Limited Sisson Road, Gloucester, GL2 0GR, United Kingdom
D08AX
CAMPHOR 0.52 % (W/W) HAMAMELIS VIRGINIANA 40.61 % (W/W) EUCALYPTUS OIL 1.04 % (W/W) ZINC OXIDE 3.11 % (W/W) METHYL SALICYLATE 1.04 % (W/W) MELALEUCA OIL 2.5 % (W/W)
CREAM
CAMPHOR 0.52 % (W/W) HAMAMELIS VIRGINIANA 40.61 % (W/W) EUCALYPTUS OIL 1.04 % (W/W) ZINC OXIDE 3.11 % (W/W) METHYL SALICYLATE 1.04 % (W/W) MELALEUCA OIL 2.5 % (W/W)
OTC
ANTISEPTICS AND DISINFECTANTS
Withdrawn
2005-12-23
_THIS LEAFLET TELLS YOU SOME IMPORTANT THINGS ABOUT _ _TEA TREE & WITCH HAZEL CREAM_ WHAT IS IN TEA TREE & WITCH HAZEL CREAM? ACTIVE INGREDIENTS W/W: Distilled Witch Hazel BPC 40.61% Eucalyptus Oil BP 1.04% Methyl Salicylate BP 1.04% Camphor BP 0.52% Tea Tree Oil BPC 2.50% Zinc Oxide BP 3.11% OTHER INGREDIENTS: Chloroxylenol BP, Emulsifying Wax BP, Lanolin BP, Menthol BP,Water,White Beeswax BP, White Soft Paraffin BP. 28g HOW DOES TEA TREE & WITCH HAZEL CREAM WORK? Tea Tree & Witch Hazel Cream is an antiseptic cream which is cooling and soothing. It also helps to relieve pain and itching. TEA TREE & WITCH HAZEL CREAM WHO MAKES TEA TREE & WITCH HAZEL CREAM? Tea Tree & Witch Hazel Cream is manufactured by the licence holder G. R. Lane Health Products Ltd., Sisson Road, Gloucester, UK, GL1 3QB. WHAT IS TEA TREE & WITCH HAZEL CREAM USED FOR? A cream for the relief of minor skin conditions such as spots, pimples, dry chapped skin, nappy rash and sunburn, as well as for the treatment of cuts, minor burns and wounds. BEFORE USING TEA TREE & WITCH HAZEL CREAM Do not use with creams or ointments containing benzyl penicillin. If you are unsure, talk to your doctor. Do not use if you are allergic to any of the ingredients. Do not use on children with a history of seizures. Do not apply to the lactating breast. Do not apply to burnt, blistered skin. HOW TO USE TEA TREE & WITCH HAZEL CREAM Apply generously to the affected area several times daily as required, and at bedtime. For cuts and wounds, wash area first. For external use only. AFTER USING TEA TREE & WITCH HAZEL CREAM If symptoms persist, consult your doctor. If you experience any unusual reactions, talk to your doctor or pharmacist. STORING TEA TREE & WITCH HAZEL CREAM Keep out of sight and reach of children. Do not use after the expiry date shown on the packaging. Do not store above 25ºC. Do not use if sealed tube has been damaged. MA 073/00501 Leaflet last revised: December 2005 xxxxxx Прочитайте повний документ
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tea Tree and Witch Hazel Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ingredients %w/w Eucalyptus Oil 1.04 Distilled Witch Hazel 40.61 Methyl Salicylate 1.04 Camphor 0.52 Zinc Oxide 3.11 Tea Tree Oil 2.50 Excipient: Wool Fat For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Cream. Smooth white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of minor skin conditions including dry chapped skin, nappy rash and sunburn. For the treatment of cuts, minor burns and wounds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use. Apply generously to the affected area several times daily when needed and at bedtime. For cuts and wounds, wash area first. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients. Page 2 of 4 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms worsen or do not improve after 7 days, a doctor should be contacted. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Zinc oxide is reported to be incompatible with benzyl penicillin. However, since this product is used topically, and benzyl penicillin is administered intravenously, there is unlikely to be any interactions if both products are used concomitantly. 4.6 PREGNANCY AND LACTATION In the absence of sufficient data the use during pregnancy and lactation is not recommended. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES This product has no influence on the ability to drive and use machines. 4.8 UNDESIRABLE EFFECTS Прочитайте повний документ