BURNEZE SPRAY 1 %w/w Cutaneous Spray Solution

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

BENZOCAINE

Verfügbar ab:

SSL International PLC

INN (Internationale Bezeichnung):

BENZOCAINE

Dosierung:

1 %w/w

Darreichungsform:

Cutaneous Spray Solution

Verschreibungstyp:

Product not subject to medical prescription

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

0000-00-00

Gebrauchsinformation

BURNEZE SPRAY 
Benzocaine 1.0% 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 any of the 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 or on broken skin or on infected skin.  
• 
In or near to the eyes or mouth, or under conditions in which
significant 
inhalation is likely. 

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 or ‘frost’
appears.  
• 
If necessary the application may be repeated once
only after 15 minutes. 

If pain persists, speak to your doctor or pharmacist. 

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

Fachinformation

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.
IRISH MEDICINES BOARD
________________________________