Alliance Pharmaceuticals Ireland

Aquadrate 10% w/w Cream.

Aquadrate cream contains Urea 10% w/w

For a full list of excipients, see section 6.1.

Cream

A smooth, unperfumed, non-greasy, off-white cream for topical administration.

For the management of ichthyosis, xeroderma, hyperkeratosis and other chronic dry skin conditions.

Aquadrate is applied topically. Wash affected areas well, rinse off all traces of soap, dry, and apply sparingly twice daily. Occlusive dressings may be used but are usually unnecessary because of the self-occlusive nature of the cream.

Known hypersensitivity to the product.

Avoid application to moist or broken skin.

Aquadrate may increase the penetration through the skin barrier of other topically applied medicaments.

Animal reproduction studies have not been conducted with Aquadrate. Aquadrate should only be used if the anticipated benefits outweigh the risks.

Aquadrate does not interfere with the ability to drive or use machines.

May cause local irritations (including erythema, burning or pruritus) and oedema when applied to sensitive skin. If the condition is aggravated or there is no improvement, the doctor should be consulted.

Topical applications of excessive amounts of Aquadrate might cause skin irritation but no other effects would be expected. Ingestion of a large amount of Aquadrate would be expected to result in gastrointestinal irritation (nausea and vomiting). Symptomatic and supportive care should be given. Liberal oral administration of milk or water may be helpful.

Urea acts as a hydrating and keratolytic agent.

Urea is primarily excreted in the urine. A small amount is also eliminated in sweat.

In man, doses of up to 80g/day iv or 100g/day p.o urea are considered safe.

Whilst only very limited preclinical data is available, there is no evidence to suggest that urea would have teratogenic, carcinogenic or mutagenic potential in therapeutic use.

The cream also contains:

White soft paraffin

Maize starch

Isopropyl myristate

Glyceryl tribehenate

Palmitic acid

Sorbitan laurate

Polyoxyethylene fatty glyceride.

Not applicable.

Three years.

Do not store above 30°C.

Aquadrate is available in tubes of 30g and 100g.

Not all pack sizes may be marketed.

No special requirements.

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire SN15 2BB

United Kingdom

PA 943/5/1

April 2010