Alliance Pharmaceuticals Ireland

Dermamist 10% w/w Dry Skin Spray

White Soft Paraffin 10% w/w.

For a full list of excipients, see section 6.1

Cutaneous Spray, solution (cutaneous spray)

A cutaneous spray delivering white soft paraffin as a clear colourless spray by means of a pressurised aerosol.

Treatment of dry skin conditions including pruritus (itching and dryness) of the elderly eczema, and ichthyosis (dry scaly skin).

Adults, children and the elderly:

Shake before use. Bathe or shower for not more than ten minutes.

Pat dry and apply spray without delay. Do not spray on face. Spray from a distance of approximately 8 inches. Spray away from the face and move the can while spraying to achieve a very light coverage of the body. Spray sparingly; over application may cause the skin to feel oily.

Hypersensitivity to any of the ingredients.

For external use only.

Keep out of reach of children.

Do not spray on face.

Use in a ventilated area.

Avoid inhalation.

Guard against slipping.

Discontinue use if the condition is made worse.

Do not apply to broken skin.

Patients being dispensed or treated with large quantities (> 100g) of any paraffin based product should be advised to regularly change clothing or bedding impregnated with the product and keep away from naked flames as there is a fire hazard.

None.

Can be used.

Not relevant.

Not relevant.

None.

Emollients are fats or oils used for their local action on the skin and, occasionally, the mucous membranes. These oleaginous substances, also known as occlusive agents and humectants, are employed as protectives and as agents for softening the skin and rendering it more pliable. White soft paraffin forms an effective occlusive lipid film. The mechanism of action is by occluding water loss from the outer layer of skin.

White soft paraffin exerts its physiological effects by forming an occlusive layer on the surface of the skin. It is effective because it is not subject to absorption or subsequent distribution in the body, excretion or metabolism. Pharmacokinetic particulars are not appropriate in these circumstances.

No relevant pre-clinical data has been generated.

Liquid paraffin

Medium chain triglycerides

Butane 40 (butane: isobutane: propane)

Not Applicable.

5 years.

Do not store above 25^oC.

Extremely flammable.

Protect from sunlight and do not expose to temperatures exceeding 50^oC.

Do not pierce or burn even when empty.

Do not spray on a naked flame or any incandescent material.

Keep away from sources of ignition – no smoking.

Pressurised aluminium aerosol can. Pack sizes: 50ml, 75ml, 100ml, 125ml, 150ml, 200ml, 250ml, 300ml, 400ml and 500ml.

Not all pack sizes may be marketed.

No special requirements.

Alliance Pharmaceuticals Limited

Bath Road

Chippenham

Wiltshire SN15 2BB

England

PA 943/15/1

Date of first authorisation: 04 April 1997

Date of last renewal: 04 April 2007

April 2010