Tiger Balm Red
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tiger Balm Red.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredient % w/w
11.0% w/w 10.0% w/w 7.0% w/w 5.0% w/w
Camphor Ph Eur Menthol Ph Eur Cajuput Oil BPC Clove Oil Ph Eur
3 PHARMACEUTICAL FORM
Ointment for cutaneous use.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the temporary relief of muscular aches and pains.
4.2 Posology and method of administration
To be rubbed gently on the affected parts of skin as necessary (usually 2 to 3 times daily).
Not to be used on children under 2 years of age.
4.3 Contraindications
Hypersensitivity to any of the ingredients in this product. 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. Keep out of reach of children. If symptoms persist after two weeks, a doctor should be consulted.
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
May give rise to hypersensitivity reactions, including contact dermatitis.
Overdose
4.9
Over 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
PHARMACEUTICAL PARTICULARS
6
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.
6.6 Special precautions for disposal
MARKETING AUTHORISATION HOLDER
7
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road LONDON SW1V 2SA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 02855/0234
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/08/1996
10 DATE OF REVISION OF THE TEXT
21/03/2016