ANHYDROL™ FORTE 20% w/v CUTANEOUS SOLUTION

Aluminium Chloride Hexahydrate 20.0% w/v.

Clear, colourless evaporative cutaneous solution.

For the topical treatment of hyperhidrosis specifically involving axillae, hands or feet.

For adults, children and the elderly: Apply to the affected sites at night, as required, and allow to dry. Wash off in the morning.

Not to be used in cases of sensitivity to any of the ingredients.

Care should be taken to restrict the application to the affected sites only. Keep away from the eyes. Care should be taken to avoid Anhydrol Forte coming into direct contact with clothing, polished surfaces, jewellery or metal. Replace cap tightly after use.

Do not bathe immediately before use and, if the axillae are treated, do not shave or use depilatories on this area within 12 hours before or after use.

No special precautions.

None known.

If applied too frequently, Anhydrol Forte may cause irritation which should be treated with a mild topical hydrocortisone cream.

See section 4.8 above (undesirable effects).

Aluminium chloride is believed to denature the protein content of sweat issuing from eccrine glands, and to combine with the intraductal keratin fibrils, producing a functional closure. The antibacterial action of the aluminium ion also precludes the development of miliaria. Accordingly, there is no secondary inflammation. The intraluminal pressure rises to the point where it acts as a feedback system, shutting off acinar secretion.

The formulation of Anhydrol Forte has been tested in widespread clinical practice, and has been shown to be effective when used in accordance with the recommended instructions.

As the active ingredient is applied in an alcoholic solution of low surface tension, it therefore penetrates into the terminal pores of the sweat ducts, when applied, as recommended, to dry skin. The alcohol then evaporates off, leaving the salt deposited in close contact with the lining of the duct. The use of the preparation is restricted to small areas of skin, namely the axillae, hands or feet, to ensure that there are no detrimental effects from widespread obstruction of sweating.

No special information.

Industrial Methylated Spirit.

None known.

36 months.

Highly flammable. Do not store above 25°C. Store upright and away from flames.

60 ml plastic bottle with roll-on applicator and screwcap. This is supplied as an original pack (OP).

Not applicable.

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

00173/0030.

17 December 2006.

July 2007.