Summary of Product Characteristics (SmPC) - Dulbalm cream
1 NAME OF THE MEDICINAL PRODUCT
Dulbalm Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ethyl Nicotinate 1%
Methyl Nicotinate 1%
Benzyl Nicotinate 1%
Glycol Salicylate 2%
Capsicum Oleoresin 0.01%
Excipient(s) with known effect:
Polysorbate 80
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
External application for the symptomatic treatment of muscle stiffness, muscular rheumatism, lumbago, sciatica, fibrositis, sprains and chilblains.
4.2. Posology and method of administration
Apply externally with gentle massage 2 - 3 times daily, avoiding broken or inflamed skin.
DO NOT APPLY TO CHILDREN UNDER 6 YEARS OF AGE.
4.3. Contra-indications
Known sensitivity to any of the ingredients.
Do not apply to children less than six years old.
4.4 Special warnings and precautions for use
Do not apply to broken or tender skin.
Application on mucous membranes should be avoided. Discontinue if rash develops.
Not for use with occlusive dressings.
Topical application may result in systemic effects, including asthma. Patients should be advised against excessive exposure of areas treated to sunlight, in order to avoid possibility of photosensitivity. Keep away from eyes.
Wash hands after use.
4.5. Interactions with other medicinal products and other forms of interaction
None known.
4.6. Fertility, pregnancy and lactation
As with most medicines, use in pregnancy or breastfeeding should be avoided.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Photosensitivity and application site 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
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
All the active ingredients in Dulbalm Cream are topical vasodilators with rubefacient activity.
5.2. Pharmacokinetic properties
External application of Dulbalm Cream to intact skin results in negligible systemic absorption.
5.3. Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Emulsifying Wax, White Soft Paraffin, Polysorbate 80, Cineole, Purified Water.
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4 Special precautions for storage
Store below 25°C.
Keep this medicine out of the sight and reach of children.
6.5. Nature and contents of container
Aluminium tube, 25g.
6.6. Special precautions for disposal
No special handling is required.
7 MARKETING AUTHORISATION HOLDER
Norma Chemicals Ltd.
51-53 Stert Street
Abingdon
Oxfordshire OX14 3JF
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00386/5007R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29 December 1983 / 28 February 1995
10 DATE OF REVISION OF THE TEXT
15/05/2025