Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mepyramine maleate; Benzocaine
G.R. Lane Health Products Ltd
n/a
Mepyramine maleate; Benzocaine
5mg/1gram ; 10mg/1gram
Spray
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13030000; GTIN: 5012509975883 5012509975876
Common Technical Document W a s p - E z e S p r a y Module 1 – Administrative and Prescribing Information Module 1.3 – Product Information January 2015 - LB Text to appear on the patient information leaflet WASP-EZE SPRAY Benzocaine 1.0% w/w and Mepyramine maleate 0.5% w/w PATIENT INFORMATION LEAFLET Please read this leaflet carefully before using Wasp-Eze Spray. • Keep this leaflet, you may wish to read it again. • Ask your pharmacist if you need more information or advice. What is this spray used for? This cutaneous spray solution is used to treat insect bites and stings, and nettle and jellyfish stings. Before using this spray Do not use… • If you are sensitivie or allergic to any of the ingredients in this product or any chemically related anaesthetics (butylcaine and tetracaine) or mepyramine maleate or para-aminobenzoic acid, parabens or paraphenylenediamine or to commercial hair dyes. See 'what this spray contains' for the full list of ingredients. • If you are pregnant or breast feeding, except on medical advice. • On broken skin or eczematous (A skin inflammation characterized chiefly by redness, itching, and the outbreak of lesions that may discharge serous matter and become encrusted and scaly), sunburnt, infected skin. Do not use the spray on the face. • Near to the eyes or mouth. Talk to your doctor or pharmacist… • If you are allergic or sensitive to insect bites or stings, please call your doctor or local hospital immediately. How to use this spray Adults, the elderly and children: • Hold the nozzle 12.5 cm (5 inches) from the bite or sting. • Press the nozzle down firmly and spray once for 2 to 3 seconds. Stop spraying immediately if a white deposit or ‘frost’ appears. • If the bite or sting still hurts, you can use the spray once more after 15 minutes If the bite or sting is still painful, please tell your doctor or pharmacist. If you accidentally swallow the spray or get it into your eyes… The spray is for external use only – do not spray in your mouth or eyes Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Wasp-Eze Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzocaine 1.0% _wlw _ Mepyramine maleate 0.5% w/w_ _ For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Aerosol spray. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of all insect bites and stings, nettle stings and jellyfish stings. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: For cutaneous application Adults, the elderly and children: Hold nozzle approximately five inches from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white deposit or ‘frost’ appears. Repeat once after 15 minutes if necessary. If pain persists, seek medical advice. 4.3 CONTRAINDICATIONS Do not use if you are sensitive to benzocaine, any chemically related anaesthetics (butylcaine and tetracaline) or mepyramine maleate. Do not use if you are sensitive to any of the excipients or to para-amino benzoic acid (PABA), parabens or paraphynylenediamine or to commercial hair dyes as there is cross-sensitivity between these products. Do not apply to large areas of skin, eczematous, sunburnt, infected or broken skin. Do not use the spray on the face. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with any known allergy should seek medical advice. If pain persists, seek medical advice. Do not use near the mouth or eyes or under conditions in which significant inhalation is likely. Not for repeated or prolonged use. For external use only. Keep out of the sight and reach of children. Flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Do not use near or place container on polished or painted surfaces. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy: There are n Read the complete document