Radian B Muscle Lotion

1. Name Of The Medicinal Product

Radian B Liniment/Radian B Muscle Lotion/Radian B Sport Muscle Lotion/ Radian B Winter Sport Muscle Lotion/ Cura Heat Pain Relief Lotion

2. Qualitative And Quantitative Composition

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

3. Pharmaceutical Form

Liniment for topical application to human beings.

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

Posology: For external application.

For Adults and Children Over 12 Years:

Apply the lotion on the affected part once or twice, leaving 10-15 minutes between applications. 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.

Children Under 12: Not recommended for children under 12.

Elderly: The adult dose is appropriate.

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. If irritation develops, use of the product should be discontinued. Pregnancy and lactation.

4.4 Special Warnings And Precautions For Use

Keep away from eyes and other sensitive areas. If symptoms persist, consult a doctor. Flammable: Do not use near naked flame. Should not be placed on or used near polished or painted surfaces.

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

Store below 25°C

6.5 Nature And Contents Of Container

Ribbed oval glass bottle with polypropylene insert and plastic cap. Polythene bottle and plastic cap. Pack sizes 50 and 100ml.

White HDPE bottle with red urea cap and wad. Pack sizes: 30, 125 and 250ml oval bottles and 500 and 2000ml round bottles.

Boston round silver HDPE bottle and silver polypropylene cap without wad. Pack size 500ml.

Silver HDPE bottle with silver coloured, black urea cap and wad and LDPE insert. Pack sizes: 125 and 250ml oval bottle.

Silver HDPE bottle with LDPE plug insert and warm red coloured, spigot seal polypropylene cap. Pack sizes: 125, 250ml and 500ml oval bottle.

White polypropylene bottle with an angled neck containing an applicator, consisting of polypropylene plug, ring and spring, encasing a red polyurethane foam, with a red polypropylene cap. Pack size 80ml.

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 00240/0359

9. Date Of First Authorisation/Renewal Of The Authorisation

30 April 2002

10. Date Of Revision Of The Text

04/03/2008