Summary of Product Characteristics (SmPC) - Tiger Balm White
1 NAME OF THE MEDICINAL PRODUCT
Tiger Balm White.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Camphor Ph Eur 11.0% w/w, Menthol Ph Eur 8.0% w/w, Cajuput Oil BPC 13.0% w/w, Clove Oil Ph Eur, 1.5% w/w.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Tiger Balm White is indicated in adults and children aged 2 years and older: For the symptomatic relief of minor muscular aches and pains. Do not use on children under 2 years.
Tiger Balm White is indicated in adults only:
For the treatment of tension headache..
4.2 Posology and method of administration
Posology
Adults and children aged 2 years and older (muscular aches and pains): Adults only (Tension headache)
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.
Paediatric population
Do not use in children.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
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).
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.
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.
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
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. 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
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 25ºC.
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. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
Wrafton,
Braunton,
Devon,
EX33 2DL,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 02855/0235
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 20th August 1996
10 DATE OF REVISION OF THE TEXT
22/09/2023