LMX4 Cream Ref.[27730] Active ingredients: Lidocaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Ferndale Pharmaceuticals Ltd, Unit 740, Thorp Arch Estate, Wetherby, West Yorkshire, LS23 7FX, United Kingdom

Product name and form

LMX4.

Lidocaine 4% w/w Cream.

Pharmaceutical Form

Cream.

A white to off-white yellowish cream.

Qualitative and quantitative composition

Lidocaine 4%w/w.

Excipient with known effect:

1 gram of cream contains 75mg of propylene glycol.

1 gram of cream contains 15mg of benzyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient 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

Benzyl alcohol
Carbomers
Cholesterol
Phospholipon 80H (Hydrogenated soy lecithin)
Polysorbate 80 (Tween 80)
Propylene glycol
Trolamine
Vitamin E acetate
Purified water

Pack sizes and marketing

The pack sizes are 5g and 30g. Both packs comprise either:

  • an aluminium tube with an epoxyphenolic internal lacquer, fitted with a polypropylene cap or
  • an aluminium tube with a polyamide-imide internal lacquer fitted with a polyethylene cap.

The following packaging options are approved but not all of these packaging options may be marketed:

  1. A carton containing one 5g tube.
  2. A carton containing five 5g tubes.
  3. A carton containing one 5g tube with two Tegaderm occlusive dressings.
  4. A carton containing five 5g tubes with ten Tegaderm occlusive dressings.
  5. A carton containing one 30g tube.

Marketing authorization holder

Ferndale Pharmaceuticals Ltd, Unit 740, Thorp Arch Estate, Wetherby, West Yorkshire, LS23 7FX, United Kingdom

Marketing authorization dates and numbers

PL20685/0034

20 November 2007/25 June 2013

Drugs

Drug Countries
LMX 4 Cyprus, New Zealand, Turkey, United Kingdom
 
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