SPC, UK: FINACEA Gel (2019)

Product Name and Form

Finacea 15 % Gel.

Pharmaceutical form

Gel.

White to yellowish-white opaque gel.

Qualitative and Quantitative Composition

1 g Finacea Gel contains 150 mg (15%) azelaic acid.

Excipients with known effect:

1 mg Benzoic acid /g Gel

0.12 g Propylene glycol /g Gel

For the full list of excipients, see section 6.1.

List of excipients

Benzoic acid (E210)
Carbomers
Disodium edetate
Lecithin
Polysorbate 80
Propylene glycol
Purified water
Sodium hydroxide
Triglycerides medium chain

Pack sizes and Marketing

Aluminium tube with internal epoxide coating and polyethylene screw cap.

Tubes of 5, 30, 50, 2 × 50 g.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

03/07/2007

Marketing authorization number:

PL 00043/0237