Alliance Pharmaceuticals Ireland

Hydromol 2.5% w/w Cream

Excipients:

Contains cetostearyl alcohol 4%w/w

Contains hydroxybenzoates (parabens) approximately 1%w/w: methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates

For full list of excipients see Section 6.1.

Cream.

Soft, white oil-in-water cream.

As a lubricant and hydrating agent in the management of dry skin conditions such as certain types of eczema, ichthyosis and senile pruritus.

Route of administration

For topical use only.

Adults, Children and the Elderly:

Apply liberally to the affected area and massage well into the skin. Hydromol Cream may be used as often as required.

Hydromol Cream is especially beneficial when used immediately after washing or bathing, when the resultant warmth of the skin enhances absorption.

There are no contraindications except true hypersensitivity to any of the ingredients.

If there is aggravation of the condition consult the doctor. The formulation is not designed for use as a diluent.

None known.

Hydromol Cream is not contra-indicated in pregnancy or lactation.

Not applicable.

Rarely a non serious allergic type reaction may be experienced, e.g. rash.

Not applicable, Hydromol Cream is for topical use only.

The combination of oils used in Hydromol Cream helps to lubricate and hydrate the skin. Moisture loss from the stratum corneum is reduced by the formation of an occlusive film by liquid paraffin on the surface of the skin. Isopropyl myristate, a fatty acid ester, is easily absorbed into the skin and helps to improve skin softness.

The combination of sodium pyrrolidone carboxylate and sodium lactate positively aids the hydration of the skin.

None stated.

Isopropyl Myristate

Liquid paraffin

Sodium Lactate

Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol and macrogol cetostearyl ether)

Myristyl Myristate

Cetomacrogol 1000

Hydroxybenzoates (Parabens): methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates

Phenoxyethanol

Purified water

Not applicable.

Two years.

Do not store above 25^oC. Store in the original container.

Hydromol Cream is packed in low density polythene tubes of 50g and 100g with a flush fitting cap. It is also available in polypropylene tubs containing 500g with pump dispenser.

Not all pack sizes may be marketed.

Any unused product or waste materials should be disposed of in accordance with local requirements.

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

United Kingdom

PA 943/13/1

Date of first authorisation: 16 May 1994

Date of last renewal: 16 May 2009

July 2010