Seven In One Rubbing Oils
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seven in One Rubbing Oils.
Bell's Seven in One Rubbing Oil.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl Salicylate BP 7%w/w
3. PHARMACEUTICAL FORM
Topical solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of muscular pain and stiffness including backache, sciatica, lumbago, fibrositis and rheumatic pain.
4.2. Posology and Method of Administration
Topical
Adults, including the elderly and children over 12 years.
Apply to the affected area and rub in gently whenever required up to 3 times a day. Not recommended for children under 12.
4.3. Contra-indications
Hypersensitivity to salicylates or other ingredients.
4.4. Special Warnings and Precautions for Use
Do not use on broken skin.
For external use only.
Keep out of reach of children.
4.5. Interaction with other Medicaments and other forms of Interaction
None known
4.6. Pregnancy and Lactation
Avoid use during pregnancy and breast-feeding.
4.7. Effects on Ability to Drive and Use Machines
None
4.8. Undesirable Effects
Sensitivity to the product may cause a pain or itching.
Turpentine oil may cause vesicular eruption, urticaria and vomiting in susceptible persons.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
If accidentally ingested seek medical advice.
5.1 Pharmacodynamic properties
Methyl salicylate is readily absorbed through the skin and is used for pain relief. The essential oils when applied to the skin have an irritant and rubefacient action causing first a sensation of warmth and smarting which is followed by a mild local anaesthesia. They are therefore used as counterirritants and cutaneous stimulants in the treatment of chronic inflammatory conditions and to relieve neuralgia and rheumatic pains.
5.2. Pharmacokinetic Properties
Methyl salicylate is readily absorbed into the body and hydrolysis to salicylic acid occurs rapidly which is excreted in the urine. Data on turpentine oil is not readily available.
5.3. Preclinical Safety Data
None available.
6 PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Nutmeg Oil BP Thyme Oil BPC 1949 Eucalyptus Oil BP Turpentine Oil BP Synthetic Camphor Oil Pumilio Pine Oil BP 1980 Technical White Oil
6.2. Incompatibilities
None known.
6.3. Shelf Life
60 months in unopened bottle
6.4. Special Precautions for Storage
Do not store above 25°C. Store in the original container.
6.5. Nature and Contents of Container
Amber glass bottles with wadless plastic caps.
Sizes: 15ml, 25ml, 28 ml, 50 ml, 60ml, 75ml, and 100ml
6.6. Instruction for Use/Handling
None
7. MARKETING AUTHORISATION HOLDER
Name or style and permanent address or registered place of business of the holder of the marketing authorisation.
Bell, Sons & Co (Druggists) Limited
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
8. MARKETING AUTHORISATION NUMBER
PL 03105/0053
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of grant 18 August 1997 Date of renewal 17 July 2000
10. DATE OF REVISION OF THE TEXT
1st April 2016.