Wasp-Eze Spray

1. Name Of The Medicinal Product

Wasp-Eze Spray.

2. Qualitative And Quantitative Composition

Benzocaine 1.0% w/w

Mepyramine Maleate 0.5% w/w

For excipients, see 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

Topical.

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 apply to broken skin.

Do not use near the eyes.

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. If pain persists seek medical advice.

For external use only. Keep out of 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

No known effects in pregnancy and lactation. However, as with all medicines, use with caution.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Skin rash. Methaemoglobinaemia, especially in infants and children.

4.9 Overdose

Overdose is unlikely with this dosage form. There are no known effects and no specific treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antipruritics, incl. Antihistamines, Anesthetics, etc., ATC code: D04A.

The active ingredients, benzocaine and mepyramine maleate, reduce pain and histamine responses to stings. The physical effects of the cooling propellants help reduce pain.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Propylene glycol

Ethanol (denatured)

Iso-butane

N-Pentane

Dimethyl ether

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Aluminium cans (30 and 60 ml) 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

Not applicable.

7. Marketing Authorisation Holder

Seton Products Ltd,

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 11314/0032.

9. Date Of First Authorisation/Renewal Of The Authorisation

15/12/94 / 13/03/00 / 13/03/05

10. Date Of Revision Of The Text

15/09/05