Summary of medicine characteristics - TIGER BALM RED
1 NAME OF THE MEDICINAL PRODUCT
Tiger Balm Red.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Camphor 11.0%w/w, Levomenthol 10.0%w/w, Cajuput Oil 7.0%w/w and Clove Oil 5.0%w/w.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the temporary relief of muscular aches and pains.
Tiger balm red is indicated in adults and children aged 2 years and older.
4.2 Posology and method of administration
Posology
Adults and children aged 2 years and older:
Method of administration
To be rubbed gently on the affected parts of skin as necessary (usually 2 to 3 times daily).
Paediatric population
Not to be used on children under 2 years of age.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Do not use on children under two years of age
4.4 Special warnings and precautions for use
For external use only. Wash hands immediately after use. Do not apply to wounds, damaged or irritated skin, discontinue use if irritation develops. Avoid contact with the eyes, mucous membranes or other tender areas. Do not bandage tightly. If symptoms persist after two weeks, a doctor should be consulted.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
4.5 Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6 Fertility, pregnancy and lactation
Avoid excessive use during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Adverse reactions reported from extensive post-marketing experience are tabulated below by System Organ Class and frequency. The following convention has been utilised for the classification of undesirable effects: Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).
| System Organ Class | Adverse Drug Reaction | Frequency |
| General disorders and administration site conditions | Burn at application site | Not known |
May give rise to hypersensitivity reactions, including contact dermatitis.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseOver dosage may result in skin irritation.
Misuse:
Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.
Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot / flushing, convulsions, respiratory depression and coma.
Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Menthol and camphor have mild analgesic and rubefacient properties.
Cajuput oil is a mild counter irritant.
Clove oil is rubefacient and slightly analgesic with preservative properties.
5.2 Pharmacokinetic properties
Camphor and menthol are well absorbed when applied topically, and produce a local effect. The absorption properties of cajuput oil are not known but clove oil appears to be poorly absorbed.
5.3 Preclinical safety data
5.3 Preclinical safety dataNone stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Dementholised Mint Oil
Cinnamon Oil
Yellow Soft Paraffin
Hard Paraffin
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Tiger Balm has a shelf life of four years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Glass screw top jar containing 19g or 30g of Tiger Balm Red, or slip lid tin containing 4 or 8g of Tiger Balm Red. Not all pack sizes may be marketed
6.6 Special precautions for disposal
6.6 Special precautions for disposalNone stated.
7 MARKETING AUTHORISATION HOLDER
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20th August 1996