Ralgex Cream.

Glycol Monosalicylate DAB 10.0% w/w; Methyl Nicotinate BP 1.0% w/w; Capsicum Oleoresin BPC 1973 0.12% w/w.

Cream.

Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain.

Adults and children aged 12 years and over: After trial use, rub into the skin until absorbed. To be applied as required to the affected area. Repeat as necessary up to four times a day. Not to be used on children under 12 years except on medical advice. The elderly: The normal adult directions for use can be followed.

Known hypersensitivity to salicylates or to any of the ingredients of the cream. Injuries involving broken skin.

Some people experience stronger effects with Ralgex than others; the product should be tried on a small area first. Do not apply near the eyes, mouth or on sensitive body areas. Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather.

None known.

No evidence of safety of this product has been determined in pregnancy. It is not necessary to contraindicate this product in pregnancy and lactation provided caution is exercised and the directions for use are followed. However, as with all medicines, the advice of a doctor should be sought before the product is used.

None stated.

Mild irritation of the skin (reddening, burning sensations and rarely swelling) have been reported, which may become more severe. Rashes have also been rarely reported.

Overuse would probably cause localised redness, swelling and burning sensations of the skin owing to the counter-irritant effect of the product. Rashes may also develop. These should subside on withdrawal of the product, but occasionally may require treatment. Where this is indicated, relief would be obtained from gently swabbing the area with gauze or white lint soaked in vegetable oil. Rarely the application of a cream or ointment containing corticosteroid may be necessary. It is most unlikely that even the most excessive use of this product would lead to sufficient percutaneous absorption of active ingredients to cause systemic effects. In the case of accidental oral ingestion, the advice of a doctor should be sought.

Pharmacotherapeutic group: other topical products for joint and muscular pain, ATC code: M02A.

Methyl nicotinate has a counter-irritant effect by a rubefacient action. It readily penetrates the cutaneous barrier to produce vasodilatation and elevation of skin temperature. Capsicum oleoresin has a counter-irritant effect by producing irritation and a transient feeling of warmth. Glycol monosalicylate provides the anti-inflammatory and analgesic action. Clinical data demonstrate that Ralgex Cream provides rapid warming relief for muscular aches and pains.

Glycol monosalicylate and methyl nicotinate are readily absorbed percutaneously.

Not applicable.

Polawax; Arlacel 165; Oleyl Alcohol; Dimethicone; Methylhydroxybenzoate; Butylhydroxybenzoate; Goliath Perfume SE 83.0502; Neutralaire D7; Deionised water.

None known.

Two years.

Store below 25^oC.

Flexible aluminium tubes containing either 40g or 100g of product, internally lacquered and having a white polypropylene screw cap. The tubes are contained in a boxboard carton.

None stated.

SSL International Plc. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA

PL 17905/0052

10/12/96, 09/01/02

September 2006