Summary of Product Characteristics (SmPC) - Balmosa cream
1 NAME OF THE MEDICINAL PRODUCT
BALMOSA CREAM
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Menthol BP 2.0%
w/w Camphor BP 4.0%
w/w Methyl Salicylate Ph.Eur. 4.0%
w/w Capsicum Oleoresin BPC 0.035%
w/w
3 PHARMACEUTICAL FORM
Cream for cutaneous use
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Analgesic/rubefacient cream for the symptomatic relief of muscular rheumatism, fibrositis, lumbago, sciatica and unbroken chilblains.
4.2 Posology and method of administration
Adults and the elderly:
Apply topically. Massage gently into the affected area as required. Wash hands immediately after use.
Children under 12 years:
Not generally recommended.
4.3 Contraindications
Hypersensitivity to aspirin, other non-steroidal anti-inflammatory drugs, or any of the ingredients listed.
4.4 Special warnings and precautions for use
For external use only.
If skin sensitivity reactions occur, discontinue use. Do not apply to inflamed or broken skin. Avoid contact with the eye and mucous membranes. Do not apply to the nostrils of infants. Do not use with occlusive dressings.
After use avoid exposing the affected area to excessive sunlight.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, pregnancy and lactation
With all salicylates there is animal evidence of teratogenicity. Use should be avoided during pregnancy and breast feeding.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable Effects
The following convention has been utilised for the classification of frequency. Very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1000 and < 1/100; rare ≥ 1/10,000 and < 1/1000; very rare < 1/10,000; not known (cannot be estimated from the available data).
| System Organ Class | Frequency | Adverse Reaction / Description |
Skin and subcutaneous
tissue disorders Rare Skin sensitivity reactions
Immune system disorders / Respiratory disorders | Not known | Topical application of large amounts may result in systemic hypersensitivity reactions and worsening of asthma |
| General disorders and administration site conditions | Not known | Burns at application site |
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
Overdosage is extremely unlikely from topical use.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Capsicum oleoresin is a rubefacient. Camphor exhibits counter-irritant and weak local anaesthetic activity. Menthol and methyl salicylate impart analgesic properties to the formulation.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methylcellulose
White soft paraffin
Emulsifying wax
Liquid paraffin
Lanolin (anhydrous)
Phenonip
Purified Water
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Aluminium tube with a polyethylene cap containing 20g or 40g of the product.
6.6 Special precautions for disposal
None stated.
7. MARKETING AUTHORISATION HOLDER
Special Concept Development (UK) Limited T/A Rx Farma Colonial Way, Watford,
Hertfordshire, WD24 4YR,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 36722/0233
9 DATE OF FIRST AUTHORISATION/RENEWAL OF
THE AUTHORISATION
29/05/2025
10 DATE OF REVISION OF THE TEXT
20/07/2026