BurnEze Spray

1. Name Of The Medicinal Product

BurnEze Spray.

2. Qualitative And Quantitative Composition

Benzocaine Ph Eur 1.0% w/w.

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

For topical administration. Adults, the elderly, and children: To reduce 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 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.

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. Flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50^oC. 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 Pregnancy And Lactation

Safety of use in pregnancy and lactation has not been established.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

May cause allergic dermatitis in sensitive individuals.

4.9 Overdose

An overdose is extremely unlikely with this type of preparation.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The active ingredient, benzocaine, is a local anaesthetic which relieves pain. The physical effects of the cooling propellants help reduce pain and blistering.

5.2 Pharmacokinetic Properties

BurnEze Spray is applied topically to the affected area.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol, Denatured; Isobutane; N-pentane.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Aluminium cans (60ml) internally coated with epoxyphenolic lacquer fitted with valve assembly and actuator button, protected by a plastic cap.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Seton Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 11314/0038.

9. Date Of First Authorisation/Renewal Of The Authorisation

15^th December 1994 / 13^th March 2000./ 16/09/2005

10. Date Of Revision Of The Text

16/09/2005