Wasp-Eze Bites and Stings Spray

1. Name Of The Medicinal Product

Wasp-Eze Bites and Stings 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

Cutaneous Spray.

A clear uniform spray.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of all insect bites and stings, nettle stings and jellyfish stings in adults and children aged 2 years and over.

4.2 Posology And Method Of Administration

For cutaneous application.

For adults and children aged 2 years and over:

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 use if you are sensitive to any of the ingredients

Do not apply to large areas of skin, eczematous, sunburnt or broken skin.

Do not use the spray on the face.

4.4 Special Warnings And Precautions For Use

Patients with any known allergy to insect bites or stings should seek medical advice. If pain persists, seek medical advice.

Not for repeated or prolonged use.

For external use only. Keep out of the reach and sight 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

Not for use in pregnancy or lactation unless on medical advice.

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

The ingredients, benzocaine (D04 AB04) and mepyramine maleate (D04 AA02), 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

Three years.

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

30 ml Aluminium cans 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 Limited

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 11314/0145

9. Date Of First Authorisation/Renewal Of The Authorisation

25^th November 2004

10. Date Of Revision Of The Text

January 2005