Tiger Balm White
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tiger Balm White.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredient % w/w
11.0% w/w 8.0% w/w 13.0% w/w 1.5% 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
Adults and children over 2 years:
For the symptomatic relief of minor muscular aches and pains. Do not use on children under 2 years.
Adults only:
For the treatment of tension headache.
4.2 Posology and method of administration
Muscular aches and pains (Adults and children over 2 years):
To be rubbed gently on the affected parts of skin as necessary (usually 2 to 3 times daily). If symptoms persist after two weeks, a doctor should be consulted (see section 4.4). Do not use on children under two years of age.
Tension headache (Adults only):
Rub the ointment onto the forehead or temples and lightly massage in a circular motion. Use a pea-sized quantity of ointment (approximately 0.5g or less), sufficient to lightly cover the affected area.
Tiger Balm White Ointment should only be applied to the forehead or the temples. Do not use in children.
4.3 Contraindications
Hypersensitivity to any of the ingredients in this product.
Asthma or other diseases of the respiratory tract that involve hypersensitivity of the airways.
Skin disease, open wounds, inflamed or irritated skin.
Use in infants and children under 2 years, due to the risk of respiratory collapse.
Non tension headache. Non tension headaches include those associated with nausea, vomiting and dizziness; visual disturbance; a unilateral headache; a headache presenting on wakening from sleep and/or following strenuous exercise.
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 apply to the nostrils or inhale. Do not bandage. Keep out of the reach and sight of children.
Muscular aches and pains: if symptoms persist after two weeks, a doctor should be consulted (see section 4.2).
Headache: if symptoms last continuously for 24 hours or recur repeatedly within the next 7 days, medical advice should be sought (see section 4.2).
Interaction with other medicinal products and other forms of interaction
4.5
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.
Substances containing menthol, camphor or cajuput oil have been reported to cause apnoea, instant collapse or laryngospasm, throat spasms or breathing difficulties in infants and young children following nasal use.
4.9 Overdose
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.
5.1 Pharmacodynamic properties
Menthol and camphor have mild analgesic and rubefacient properties. Camphor is also a counter-irritant.
Cajuput oil is a stimulant and mild rubefacient.
Clove oil is counter-irritant and mild 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
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Dementholised Mint Oil Yellow Soft Paraffin Hard Paraffin
Incompatibilities
6.2
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 White, or slip lid tin containing 4 or 8g of Tiger Balm White.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road LONDON SW1V 2SA United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 02855/0235
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/08/1996
10 DATE OF REVISION OF THE TEXT
21/03/2016