Ralgex Freeze Spray

1. Name Of The Medicinal Product

Ralgex Freeze Spray.

2. Qualitative And Quantitative Composition

Glycol Monosalicylate 10.0% w/w; Isopentane 67.77% w/w; Methoxymethane 14.41% w/w.

3. Pharmaceutical Form

Topical spray.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain. Symptomatic relief of sprains, strains and bruises associated with sports injuries, and stiffness following sporting exercise.

4.2 Posology And Method Of Administration

External application to the skin. Adults, the elderly and children aged 5 years and over: Hold the container about 6 inches from the skin with the arrow pointing to the site of pain. Press the button to spray in 2-3 short bursts. This may be repeated up to 4 times daily. Not to be used on children under five years of age.

4.3 Contraindications

Salicylate hypersensitivity. Injuries involving broken skin. Raynaud's disease. Known hypersensitivity reactions (eg. asthma, rhinitis or urticaria) in response to aspirin or any other non-steroidal anti-inflammatory drugs (including when taken orally).

4.4 Special Warnings And Precautions For Use

Some people experience stronger effects with Ralgex than others. Try on a small area first. Not for use with occlusive dressings. Do not spray on head or neck. Avoid inhalation and contact with eyes. Always spray sparingly: over application can cause discomfort. Do not spray on sensitive body areas or broken skin. If symptoms persist, consult a doctor. For external use only. Keep out of the reach of children. Caution: extremely flammable. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50^oC. Do not pierce or burn, even after use. Keep away from sources of ignition - no smoking. Do not spray on a naked flame or any incandescent material. Avoid contact with polished surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use during pregnancy is not contraindicated. However, as with all medicines during pregnancy and lactation, caution should be exercised.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Mild irritation of the skin has been attributed to locally applied salicylate preparations on rare occasions.

4.9 Overdose

Prolonged and excessive spraying may temporarily freeze the skin and possibly cause reversible skin frost damage. Salicylate absorption is unlikely to reach the systemic levels associated with overt salicylate poisoning. If accidentally ingested, treatment should be symptomatic. Overdosage resulting from intentional abusive inhalation of propellants could cause CNS depression, palpitations, cardiac arrhythmias and ultimately asphyxiation. Treatment: After withdrawal of the product, the treatment is symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycol monosalicylate is a topical analgesic/anti-inflammatory agent. Isopentane and methoxymethane are a propellant/refrigerant mixture in an appropriate ratio that provides a counter-irritant effect through rapid skin cooling and associated numbing.

5.2 Pharmacokinetic Properties

Isopentane and methoxymethane: These remain on the skin surface for a period of seconds only, prior to evaporation, therefore no percutaneous absorption occurs. Glycol monosalicylate: adequate absorption of glycol monosalicylate through intact skin has been demonstrated in the literature. Salicylates are extensively bound to plasma proteins and rapidly distributed. They are rapidly excreted in conjugated form.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Isopropyl Alcohol; Levomenthol.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months unopened.

6.4 Special Precautions For Storage

Protect from sunlight and do not expose to temperatures exceeding 50^oC.

6.5 Nature And Contents Of Container

Printed aerosol cans fitted with an arrowed valve and covered with a protective cap containing 125ml of product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Seton Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 11314/0072.

9. Date Of First Authorisation/Renewal Of The Authorisation

11^th September 1996 / 24^th January 2002.

10. Date Of Revision Of The Text

January 2002.