Alliance Pharmaceuticals Ireland

Meted 3% & 5% w/w Shampoo

Shampoo

A yellow viscous liquid with a characteristic odour.

For the relief of itching, irritation, redness, flaking and/or scaling due to dandruff, seborrhoeic dermatitis, or psoriasis of the scalp.

For topical administration.

Adults:

The hair should be thoroughly wetted and sufficient Meted Shampoo applied to produce an abundant lather. The hair should be rinsed and the procedure repeated.

Children:

As for adults.

Elderly:

As for adults.

Meted Shampoo is contra-indicated in persons with a sensitivity to any of the ingredients.

Avoid contact with the eyes. If shampoo gets into the eyes rinse thoroughly with water.

If the condition worsens or does not improve after regular use of the product as directed, consult a physician.

None known.

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

Safety has not been established in either humans or animals during pregnancy and lactation. However, with the small amounts of salicylic acid absorbed transdermally from Meted it is unlikely that use will cause any adverse effects.

None known.

There have been no reports of adverse effects following the use of Meted Shampoo. However, salicylic acid is a mild irritant and may cause dermatitis.

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

There is no evidence of systemic absorption following the use of this shampoo.

There are no reports available of its ingestion.

Early symptoms are ringing in the ear tinnitus with deafness, epistaxis, nausea, vomiting, sensitivity and dryness of the mucous membranes. If this occurs treatment must be stopped immediately.

Sulphur is a keratolytic and mild antiseptic.

Salicylic acid has keratolytic and fungicidal properties.

There is no evidence of systemic absorption of sulphur or salicylic acid following use of Meted Shampoo.

None presented.

Magnesium aluminium silicate

Hypromellose

Panthenol

Sodium laureth sulphate

Sodium cocoyl sarcosinate

Cocamido propyl betaine

Fragrance - 430 015

Purified water

None known.

3 years.

Do not store above 30°C.

Meted Shampoo is supplied in a white HDPE bottle with a white polypropylene screw cap. Each bottle contains either 30ml or 120ml of Meted Shampoo.

No special requirements.

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire, SN15 2BB

UK

PA 943/11/1

26^th October 1995/26^th October 2005

11^th March 2009