Common Technical Document    Burneze Spray

Module 1 - Administrative and Prescribing Information Module 1.3 - Product Information

Text to appear on the Patient Information Leaflet

BURNEZE SPRAY

Benzocaine 1% w/w

PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before using Burneze 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?

Burneze Spray contains local anaesthetic called Benzocaine which relieves pain. This spray solution is applied to the skin to relieve pain from minor superficial burns and scalds, where the skin is unbroken.

Before using this spray

Do not use...

•    If you are allergic to the active ingredient or to any of other ingredients in this product or any chemically related anaesthetics (butylcaine and tetracaine) or para-aminobenzoic acid, parabens or paraphenylenediamine or to commercial hair dyes. See 'what this spray contains' for the full list of ingredients.

•    On large areas, eczematous (A skin inflammation characterized chiefly by redness, itching, and the outbreak of lesions that may discharge serous matter and become encrusted and scaly), infected or on broken skin or on face.

•    In or near to the eyes or mouth, or under conditions in which significant inhalation is likely.

•    On children under 12 years old

Take special care...

•    If you are pregnant or breast feeding speak to your doctor or pharmacist before using.

•    Burneze spray is for external use only.

•    Avoid freezing the skin by repeated or prolonged use.

Seek medical attention if the burns are extensive (especially in young children or if they affect fingers, toes or sensitive areas).

How to use this spray

To reduce pain and blistering use Burneze spray as quickly as possible.

•    Hold the nozzle 12.5 cm (5 inches) from the skin.

•    Press down firmly and spray once for 2 to 3 seconds.

Stop spraying straight away if a white deposit (frost) appears.

•    If necessary the application may be repeated once only after 15 minutes.

If pain persists, speak to your doctor or pharmacist.

Common Technical Document    Burneze Spray

Module 1 - Administrative and Prescribing Information Module 1.3 - Product Information

Possible side effects

As with all medicines, this spray can have side effects in some people.

•    In sensitive people it may allergic skin reactions, such as itching, redness, blisters, nettle rash (hives).

•    General allergic reactions

•    A blood condition called methaemoglobinaemia which can cause headache, breathlessness and blue-tinged skin, may occur rarely, especially in infants and children.

If you feel you are reacting badly to this medicine in any way, or notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store this spray

•    Keep out of the sight and reach of children.

•    Do not store above 25°C and keep away from heat and sunlight.

•    Caution 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 use near or place container on polished or painted surfaces.

•    Do not use after expiry date shown base of the can.

•    If you find that you still have this medicine after its expiry date, return it to your local pharmacist who will dispose of it properly.

What this spray contains

Burneze spray contains % by weight of the active ingredient benzocaine.

It also contains denatured ethanol, n-pentane and iso-butane.

The physical effect of the cooling excipients helps reduce pain and blistering.

Burneze spray is available in aluminium cans containing 60ml of cutaneous spray, solution to be applied topically to the affected area.

Marketing Authorisation Holder: G R Lane Health Products Ltd. Sisson Road, Gloucester, GL2 0GR UK

Manufactured by: ColepCCL Rapid-Spray GmbH & Co. KG, Fockestrasse 12, 88471 Laupheim, Germany.

Date of revision: September 2013

Product license number; PL 01074/0239

Burneze is a trade mark of G R Lane Health Products Ltd.

January 2015 - LB