AMETOP 4% w/w Gel Ref.[7959] Active ingredients: Tetracaine

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom

Product name and form

Ametop Gel 4% w/w.

Pharmaceutical Form
Topical, white opalescent gel, each gram containing 40mg of tetracaine base.

Qualitative and quantitative composition

Tetracaine base 4.0% w/w.

Active Ingredient	Description
Tetracaine	Tetracaine is a local anaesthetic and is believed to act by blocking nerve conduction mainly by inhibiting sodium ion flux across the axon membrane.

List of Excipients
In addition to the active ingredient, Ametop gel contains: Sodium Hydroxide B.P Sodium methyl-p-hydroxybenzoate B.P Sodium propyl-p-hydroxybenzoate B.P Monobasic potassium phosphate USNF Xanthan gum USNF Sodium chloride E.P Purified water E.P.

Pack sizes and marketing

1.5g, internally lacquered, aluminium collapsible tubes, designed to deliver 1.0g of Ametop gel on squeezing.

Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom

Marketing authorization dates and numbers

PL 16853/0150

10/07/1995 / 09/10/2006

Drugs

Drug	Countries
AMETOP	Canada, Ireland, New Zealand, United Kingdom, South Africa

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