4HEAD™ CUTANEOUS STICK

Levomenthol 100% w/w.

Cutaneous Stick.

For the relief of headaches.

4head is to be applied gently to the forehead. To be used as required, but excessive use avoided. If symptoms persist or worsen seek medical advice. For external topical application only.

Not recommended in patients where there is a known hypersensitivity to menthol.

Keep away from the eyes, levomenthol is irritant if allowed to come into contact with the eyes.

For single patient use only. For topical use - not to be taken.

None known.

There is no information on safety when used during pregnancies and breast feeding, but there should be no hazard when applied as advised.

None known.

Menthol may give rise to hypersensitivity reactions including contact dermatitis. Because levomenthol is volatile, in rare cases it may cause temporary, mild watering of the eyes.

If accidentally ingested menthol is reported to cause severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness and coma. Treatment for accidental ingestion is by emptying the stomach by gastric lavage. A saline laxative and activated charcoal should be administered. Convulsions may be controlled by the slow intravenous administration of diazepam. Haemodialysis with a lipid dialysate has been employed.

Applied to the skin, menthol dilates local blood vessels, causing a sensation of coldness, followed by an analgesic effect.

After absorption, menthol is excreted in the urine and bile as the glucuronide.

No special information.

None.

None known.

60 months.

Do not store above 25˚C.

To be kept away from heat. (Melts at about 43˚C).

Plastic twist-up dispenser containing 3.6 g menthol, with plastic cover.

To be applied as directed. For single patient use only.

Diomed Developments Limited

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

00173/0193.

12 January 2009.

January 2009.