W
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 50oC. 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 25oC.
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
Wasp Eze Spray
.
