Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
BENZOCAINE
GR Lane Health Products Ltd
D04AB04
BENZOCAINE
1 %w/w
Cutaneous Spray Solution
Product not subject to medical prescription
Anesthetics for topical use
Authorised
2015-02-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Burneze Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzocaine 1 % w/w. _For full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Cutaneous spray, solution. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of pain from minor superficial burns and scalds where the skin is unbroken. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: for topical administration. Adults, the elderly and children: To reduce pain and blistering use Burneze Spray as quickly as possible. Hold nozzle five inches (10 cm) from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white frost deposit (frost) appears. If necessary, the application may be repeated once only after 15 minutes. If pain persists seek medical advice. 4.3 CONTRAINDICATIONS Do not use if you are sensitive to benzocaine or any chemically related anaesthetics (butylcaine and tetracaine). Do not use if you are sensitive to any of the excipients or to PABA, parabens or paraphenylenediamine or to commercial hair dyes as there is cross-sensitivity between these products. Do not use on broken or infected skin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with any known allergy should seek medical advice. Do not apply to large areas or to broken skin. Do not use in or near the mouth or eyes or under conditions in which significant inhalation is likely. Avoid freezing the skin by repeated or prolonged use. Seek medical advice immediately if burns are extensive (particularly in young children or if they affect fingers, toes or sensitive areas). For external use only. Keep out of the reach of children. HEALTH PRODUCTS REGULATORY AUTHORITY _________________ Прочитать полный документ