Radian B Muscle Rub

1. Name Of The Medicinal Product

Radian B Muscle Rub or Askit Muscle Rub or Radian Massage Cream or Radian B Sport Muscle Rub.

2. Qualitative And Quantitative Composition

Menthol	2.54% w/w
Camphor	1.41% w/w
Methyl Salicylate	0.42% w/w
Camphor Oil, White	0.32%w/w
Oleoresin Capsicum 500,000 Water soluble (equivalent to 0.000125% capsaicin)	0.005% w/w
Camphor and Camphor Oil, White are collectively declared as: Camphor BP	1.43% w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of muscular and rheumatic aches and pains, including; muscular stiffness, bruising, sprains, fibrositis.

4.2 Posology And Method Of Administration

For external use application.

Adult and children over 6

Apply to the affected parts and slowly massage well into the skin. For muscular strains and stiffness it is best used after a hot bath.

Elderly

The adult dose is appropriate

Children

Not recommended for children under 6.

4.3 Contraindications

Not to be used on children under 6 years old.

Do not apply to skin abrasions.

Do not apply to irritated skin

4.4 Special Warnings And Precautions For Use

Keep away from eyes and sensitive areas. If symptoms persist consult a doctor.

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

There is no, or inadequate evidence of safety in human pregnancy. Use in pregnancy only when there is no safer alternative. Use in lactation is acceptable.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Use sparingly on tender skin and 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 Massage Cream is a smooth, off-white cream which incorporates menthol, camphor, methyl salicylate, capsicine and white camphor oil as active ingredients and glycerol as emollient.

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. Methyl salicylate has the actions of the salicylates. It is readily absorbed through the skin and has counter-irritant properties. Capsicine has counter-irritant properties and white camphor oil is a rubefacient and mild counter-irritant.

5.2 Pharmacokinetic Properties

None available

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Argobase S.1

(contains: Lanolin, Lanolin alcohol, Cetostearyl alcohol, Liquid paraffin)

Emulsifying Wax

White Petroleum Jelly

2,4-dichlorobenzyl alcohol

Imidurea

Industrial Mehtylated Spirit 95

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Lacquered aluminium tube and plastic cap. White plastic screw-cap jar. Pack sizes: 15, 25, 40, 70, 100, 650gm.

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 00240/0360

9. Date Of First Authorisation/Renewal Of The Authorisation

30^th April 2002

10. Date Of Revision Of The Text

December 2003