PSORIDERM™ CREAM

Distilled Coal Tar 6.0% w/w; Lecithin 0.4% w/w.

Buff coloured cream.

For the topical treatment of sub-acute and chronic psoriasis, including psoriasis of the scalp and flexures.

For adults, children and the elderly. Apply to the affected area once or twice daily, or as recommended by the physician. Wash hands after use.

Not to be used for acute, sore or pustular psoriasis or in the presence of infection. Not to be used in cases of sensitivity to any of the ingredients.

Keep away from the eyes and mucous membranes, genital or rectal areas. Avoid cuts and grazes or infected skin. The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people. Replace cap after use. Avoid spillage.

None known.

No special precautions.

None known.

Local side-effects do not normally occur. In rare cases of skin irritation, acne-like eruptions or photosensitivity, discontinue treatment. Rarely, Psoriderm Cream may stain skin, hair or fabric.

There are no known toxic effects resulting from excessive use of Psoriderm Cream.

Coal tar has been used dermatologically for hundreds of years and has been shown to be safe and effective in the treatment of scaly skin conditions such as psoriasis. The British Pharmacopoeia contains monographs on coal tar and coal tar solution, and many formulations of coal tar are used in hospitals throughout the country. The coal tar used in Psoriderm Cream has been specially distilled and is based on a neutral fraction which has been shown to be effective in the treatment of psoriasis.

The precise mechanism of action of coal tar is not understood, largely as a result of it comprising up to 10,000 components. There is evidence that topical application of coal tar improves psoriasis by reducing the excessive rate of mitotic epidermal cell division.

Lecithin is a well known phospholipid which is present in foodstuffs. It is added to Psoriderm Cream to soften psoriasis scales and thereby enhance the absorption of the coal tar.

Not applicable.

No relevant information additional to that contained elsewhere in the SPC.

Stearic Acid; Isopropyl Palmitate; Propylene Glycol; Triethanolamine; Phenoxyethanol; Purified Water.

None known.

36 months.

Do not store above 25°C.

Amber glass jar containing 225 ml. This is supplied as an original pack (OP).

Not applicable.

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

00173/5000R.

16 February 2006.

February 2006.