Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS Trading as Stiefel: Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Isotrex Gel.
| Pharmaceutical Form |
|---|
|
Gel for topical application. |
Isotretinoin 0.05% w/w.
Excipients with known effect: Butylated Hydroxytoluene
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Isotretinoin |
Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action of isotretinoin has not yet been elucidated in detail, but it has been established that the improvement observed in the clinical picture of severe acne is associated with suppression of sebaceous gland activity and a histologically demonstrated reduction in the size of the sebaceous glands. Furthermore, a dermal anti-inflammatory effect of isotretinoin has been established. |
| List of Excipients |
|---|
|
Butylated hydroxytoluene |
Aluminium tube of 5g, 15g, 25g, 30g, 50g, 60g fitted with a screw cap.
Not all pack sizes may be marketed.
GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Trading as Stiefel: Stockley Park West, Uxbridge, Middlesex, UB11 1BT
PL 19494/0063
20/12/2005
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