Alliance Pharmaceuticals Ireland

Acnisal 2%w/w Cutaneous Solution

Salicylic Acid 2.0% w/w.

For a full list of excipients, see Section 6.1.

Cutaneous solution

An opaque off-white cutaneous emollient solution.

Acnisal is for the management of acne. It helps prevent new comedones (blackheads and whiteheads) papules and pustules (acne pimples).

For topical administration.

Adults:

Acnisal is used to wash the affected area 2 to 3 times daily. Lather with warm water,massage into skin, rinse and dry.

Children:

As for adults.

Elderly:

As for adults.

Acnisal is contra-indicated in persons with a sensitivity to salicylic acid.

For external use only. Avoid contact with the mouth, eyes and other mucous membranes to avoid irritation.

As with other topical preparations containing salicylic acid, excessive prolonged use may result in symptoms of salicylism.

None known.

No limitations to the use of Acnisal during pregnancy or lactation are known.

None known.

Salicylic acid is a mild irritant and may cause skin irritation. If undue skin irritation develops or increases adjust the usage schedule or consult your physician.

Not applicable.

Human comedones, naturally or coal tar induced, are firmly anchored and are dislodged with great difficulty. Most classic "peeling" agents are ineffective: they are merely irritants which cause scaling, creating the illusion of comedolysis. While salicylic acid is an irritant its efficacy is dependent on specific pharmacological effects. It seems to detach horny cells from each other by weakening the intercellular cement. As a result, the comedones tend to undergo disorganisation. The effect is probably a good deal more complex. Salicylic acid penetrates skin readily and increases turnover which also favours exfoliation of the comedo. In concentrations of 0.5 to 2% it significantly reduces the formation of microcomedones, which are the precursors of all other acne lesions.

There is no evidence of any systemic absorption from the use of Acnisal.

None presented.

Purified water

Benzyl alcohol

Sodium chloride

Sodium C14-C16 olefin sulphonate

Lauramide DEA

PEG-7 Glyceryl cocoate

Acrylic styrene copolymer

Not applicable.

3 years.

Store below 25^oC. Store in the original bottle.

Acnisal is supplied in a white HDPE bottle with a white polypropylene screw cap. Each bottle contains either 30ml or 177ml of Acnisal.

Not all pack sizes may be marketed.

No special requirements.

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire SN15 2BB

England

PA 943/8/1

Date of first authorisation: 22 December 1992

Date of last renewal: 22 December 2007

16^th February 2010