RADIAN B MUSCLE RUB

Active substance: METHYL SALICYLATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Radian B Muscle Rub
Radian Massage Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol
Camphor
Methyl Salicylate
Camphor Oil, White
Oleoresin Capsicum 500,000 Water
soluble (equivalent to 0.000125%
capsaicin)
Camphor and Camphor Oil, White
are collectively declared as:
Camphor

3

2.54% w/w
1.41% w/w
0.42% w/w
0.32%w/w
0.005% w/w

1.43% w/w

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
Adults 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
Do not use on children under 6 years old.

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.
Contraindicated in patients who are hypersensitive to salicylates or to any
other ingredient in the preparation. If irritation develops, use of the product
should be discontinued.

4.4

Special warnings and precautions for use
Keep away from eyes and sensitive areas. If symptoms persist consult a
doctor.
Wash hands thoroughly after use.
The excipients cetostearyl alcohol and lanolin may cause local skin reactions
(e.g. contact dermatitis).
Labels state:
Keep out of the reach and sight of children.
For external use only.

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. Menthol has also been reported to interact
with warfarin (when taken orally), decreasing its effectiveness.

4.6

Fertility, Pregnancy and lactation
There is no, or inadequate evidence of safety in human pregnancy or lactation.
As a precautionary measure, Radian B Muscle Rub should only be used during
pregnancy or lactation when there is no safer alternative.

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. Irritation of the skin may
also be caused by the capsicum oleoresin in this product.

4.9

Overdose

When used externally as directed, overdose is unlikely. However, symptoms
of systemic salicylate poisoning have been reported after the application of
salicylates to large areas of skin or for prolonged periods. Salicylism may also
occur in the unlikely event of large quantities being ingested.
Salicylate poisoning
Common features include vomiting, dehydration, tinnitus, vertigo, deafness,
sweating, warm extremities with bounding pulses, increased respiratory rate
and hyperventilation. Some degree of acid-base disturbance is present in most
cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high
arterial pH (normal or reduced hydrogen ion concentration) is usual in adults
and children over the age of four years. In children aged four years or less, a
dominant metabolic acidosis with low arterial pH (raised hydrogen ion
concentration) is common. Acidosis may increase salicylate transfer across the
blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia,
hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular
coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and
convulsions are less common in adults than in children.
Management
Activated charcoal may be administered if significant quantities have been
ingested within an hour of presentation. The plasma salicylate concentration
should be measured, although the severity of poisoning cannot be determined
from this alone and the clinical and biochemical features must be taken into
account. Elimination is increased by urinary alkalinisation, which is achieved
by the administration of 1.26% sodium bicarbonate. The urine pH should be
monitored. Correct metabolic acidosis with intravenous 8.4% sodium
bicarbonate (first check serum potassium). Forced diuresis should not be used
since it does not enhance salicylate excretion and may cause pulmonary
oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be
considered in patients with plasma salicylate concentrations >700mg/L
(5.1mmol/L), or lower concentrations associated with severe clinical or
metabolic features. Patients under ten years or over 70 have increased risk of
salicylate toxicity and may require dialysis at an earlier stage.
Camphor and Menthol
Ingestion of the product or excessive use may also lead to camphor poisoning,
the symptoms of which include nausea, vomiting, epigastric pain, headache,
dizziness, oropharyngeal burning, delirium, muscle twitching, epileptiform
convulsions, CNS depression and coma. Breathing is difficult and the breath
has a characteristic odour; anuria may occur. Death from respiratory failure or
status epilepticus may occur; fatalities in children have been recorded from 1g.
Supportive care, including anticonvulsant therapy, is the mainstay of treatment
of camphor intoxication. Gastric lavage may be considered if the patient

presents within 1 hour of ingestion; any convulsions must be controlled first.
Activated charcoal may be given orally.
Ingestion of significant quantities of menthol is reported to cause symptoms
similar to those seen after ingestion of camphor, including severe abdominal
pain, nausea, vomiting, vertigo, ataxia, drowsiness, and coma; they may be
managed similarly.

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 Methylated Spirit 95
Purified Water

6.2

Incompatibilities
None known

6.3

Shelf life
36 months

6.4

Special precautions for storage
Store below 25ºC

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
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
30/04/2002

10

DATE OF REVISION OF THE TEXT
09/01/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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