METHYL SALICYLATE LINIMENT B.P.
Active substance(s): METHYL SALICYLATE
NAME OF THE MEDICINAL PRODUCT
Methyl Salicylate Liniment B.P.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl Salicylate 25.0% v/v
For excipients, see 6.1.
For the relief of muscular and rheumatic pains, sciatica, lumbago, fibrositis, sprains
and strains of ligaments and tendons, bruises and muscle stiffness.
Posology and method of administration
Adults, children and the elderly
Rub in gently as required.
Hypersensitivity to arachis oil and sensitivity to salicylates.
Special warnings and precautions for use
Methyl Salicylate Liniment B.P. contains arachis oil (peanut oil) and should not be
applied by patients known to be allergic to peanut. As there is a possible relationship
between allergy to peanut and allergy to soya, patients with soya allergy should also
avoid Methyl Salicylate Liniment B.P.
The product is for external use only and should not be taken by mouth. Contact with
eyes, mucous membrane, inflamed or broken skin should be avoided.
Interaction with other medicinal products and other forms of interaction
Potentiation of warfarin anticoagulation has been reported following topical
application of methyl salicylate.
Pregnancy and lactation
No significant problems have been reported thought, as with all medicines, it should
be used under medical supervision in pregnant or lactating women.
Effects on ability to drive and use machines
Urticaria and angioedema have been reported in aspirin-sensitive patients.
As the product is for topical use the likelihood of overdosage due to ingestion is
small. Should it occur then treatment includes induction of emesis followed by
supportive therapy accompanied by gastric lavage. Charcoal haemoperfusion has
been used in the treatment of poisoning with methyl salicylate. As little a 4 ml has
caused death in infants.
Methyl salicylate is absorbed through the skin and relieves pain in rheumatic and
other conditions of sprains and muscle stiffness etc.
Methyl salicylate is absorbed through the skin.
It is rapidly hydrolysed to salicylic acid, mainly in the liver and excreted, mainly by
the kidney, as salicylic acid, as salicyluric acid, as salicylic phenolic and acyl
glucuronide, and as gentisic acid. The excretion is pH dependent with up to 30%
being excreted as salicylic acid under alkaline conditions and as low as 2% under acid
The plasma half- life of salicylates is 2-3 hours.
Preclinical safety data
No relevant data.
List of excipients
No significant incompatibilities have been reported though it is a “phenol” and as
such will react with certain metal salts e.g. iron.
Special precautions for storage
Store below 250C.
Nature and contents of container
500 ml and 2000 ml dispensing packs:
Amber glass bottle with a white plastic screw cap with an aluminium foil lined EPE
Patient packs or OTC packs as appropriate:
100 ml and 200 ml amber glass bottles with plastic Jay cap closures.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park,
Unit 7, Hardicker Street,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
14th April 2005
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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