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XYLOCAINE Spray (2018)

Active ingredients: Lidocaine

Product Name and Form

Xylocaine 10 mg Spray.

Pharmaceutical form

Non-sterile solution for topical application supplied in a pump spray, with nozzles for single use in an individual patient.

Qualitative and Quantitative Composition

Lidocaine 10 mg/metered dose.

Excipient(s) with known effect: Each depression also delivers 1 mg of propylene glycol (an excipient of the banana essence).

Also contains ethanol.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Lidocaine

Lidocaine, like other local anaesthetics, causes a reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ions through the nerve membrane. Local anaesthetics of the amide-type are thought to act within the sodium channels of the nerve membrane.

List of excipients

Ethanol
Macrogol 400
Essence of banana (contains propylene glycol)
Levomenthol
Saccharin
Water purified

Pack sizes and Marketing

50 ml glass spray bottles (approx. 500 spray doses) with a metering spray pump. The package includes a single use plastic spray nozzle approximately 120 mm long. Additional short spray nozzles are available separately.

Each depression of the metered spray pump delivers 10 mg lidocaine base. The contents of the spray bottles are sufficient to provide approximately 500 sprays.

Marketing authorization holder
Authorization dates

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Date of first authorisation: 25th August 1989

Date of last renewal: 7th May 2002

Marketing authorization number:

PL 39699/0086