Burneze Spray

Nazione: Malta

Lingua: inglese

Fonte: Malta Medicines Authority

Principio attivo:

BENZOCAINE

Commercializzato da:

Seton Products Limited Tubiton House, Medlock Street, Oldham, United Kingdom

Codice ATC:

D04AB04

INN (Nome Internazionale):

BENZOCAINE 1 % (W/W)

Forma farmaceutica:

CUTANEOUS SPRAY

Composizione:

BENZOCAINE 1 % (W/W)

Tipo di ricetta:

OTC

Area terapeutica:

ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2007-12-10

Scheda tecnica

 
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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF MEDICINAL PRODUCT 

Burneze Spray 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Benzocaine 
1.0% w/w 

For excipients, see 6.1. 

3. PHARMACEUTICAL 
FORM 

Aerosol spray. 

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 
_ _
Topical. 

Adults, the elderly and children aged over 12 years: 

To reduce the pain and blistering use Burneze Spray as quickly
as possible. 

Hold nozzle five inches from the skin and spray once for 2-3
seconds. Stop spraying 
immediately if a white deposit or ‘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. Not for use in children
under 12 years of age. 

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. 

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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  INTERA