Radian B Pain Relief Spray

1. Name Of The Medicinal Product

Radian B Pain Relief Spray / Fiery Jack Pain Relief Spray

2. Qualitative And Quantitative Composition

Menthol BP	1.4%w/v
Camphor BP	0.6%w/v
Aspirin BP	1.2%w/v
Equivalent to ammonium salicylate	1.0%w/v
Methyl Salicylate BP	0.6%w/v
Equivalent to salicylic acid (as Methyl and Ethyl Esters)	0.54%w/v

3. Pharmaceutical Form

Spray for topical application to human beings

4. Clinical Particulars

4.1 Therapeutic Indications

For symptomatic relief of muscular and rheumatic aches and pains, including fibrositis, sciatica, lumbago, sprained ligaments, bruises, muscle stiffness, strains, tennis elbow, golf shoulder

4.2 Posology And Method Of Administration

For external application

For Adults and Children Over 12 years:

Aerosol spray can:

Spray in 2 or 3 short firm bursts onto the affected area, followed by a second application after 10-15 minutes.

Pump action spray:

Spray as required on the affected area followed by a second application after 10-15 minutes.

Aerosol spray can and Pump action spray:

Smooth in or massage if preferred. If necessary, repeat application up to three times daily, reducing to morning and evening when acute symptoms subside.

When convenient, use after a warm bath.

Elderly:

The adult dose is appropriate.

Children Under 12:

Not recommended.

4.3 Contraindications

Not to be used on children under 12 years old. Do not apply to skin abrasions. Do not apply to irritated skin. Not to be used by persons who are sensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Do not use near the face, eyes and other sensitive areas. If symptoms persist, consult a doctor.

Flammable: Do not spray near naked flame or hot surface. Should not be placed on or used near polished or painted surfaces. Do not use in confined spaces, and avoid inhaling the spray.

Aerosol can only. Do not expose to sun or excessive heat. Contents under pressure. Do not puncture, force open or burn even when empty.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin.

4.6 Pregnancy And Lactation

Use of the product during pregnancy and lactation is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

If used on tender skin do not cover immediately after application. If an adverse reaction occurs, discontinue use immediately. Known side effects of menthol-contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.

4.9 Overdose

When used externally as directed, overdose is unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Radian B is manufactured using the following active ingredients; menthol, camphor, aspirin and methyl salicylate. The finished product contains menthol, camphor, ammonium salicylate and a mixture of methyl and ethyl esters of salicylic acid. The product provides salicylate ions which have analgesic properties. Methyl and ethyl salicylate are readily absorbed through the skin and have counter-irritant properties. Menthol relieves itching, dilates the vessels causing a sensation of coldness followed by an analgesic effect. Camphor acts as a rubefacient and mild analgesic and is employed as a counter-irritant.

5.2 Pharmacokinetic Properties

The active ingredients are well-documented pharmacopoeial ingredients. The extent of percutaneous absorption in human volunteers of (14C) acetyl salicylic acid from Radian B was studied and estimated by measurement of blood and urinary concentrations of radioactivity. Significant absorption through the skin was indicated by the excretion of almost 10% of the applied radioactivity in the urine within 5 days with approximately 5.5% in the first 24 hours.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 List Of Excipients

Industrial Methylated Spirit 95

Glycerol

Citronella Oil

Ammonia '880'

Water (purified)

6.2 Incompatibilities

None known.

6.3 Shelf Life

60 months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Trimline 'Bican' pressurised with nitrogen gas (140ml) or white or silver HDPE bottle pump action spray unit (100 or 120ml) with a silver or warm red polypropylene cap.

Pack sizes: 100ml, 120ml, 140ml

6.6 Special Precautions For Disposal And Other Handling

No special precautions necessary

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0361

9. Date Of First Authorisation/Renewal Of The Authorisation

30^th April 2002

10. Date Of Revision Of The Text

03/08/2010