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Brulidine 0.15 %w/w Cream

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Active Ingredient:
dibrompropamidine isetionate
Company:  
Tillomed Laboratories Ltd See contact details
ATC code: 
D08AC01
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About Medicine
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Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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Last updated on emc: 04 Aug 2026

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Undesirable Effects Pharmacological Properties Interactions Posology Contraindications Excipients Storage precautions
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1. Name of the medicinal product

Brulidine Cream

Brulidine Burn Treatment 0.15%w/w Cream

2. Qualitative and quantitative composition

Dibrompropamidine isetionate 0.15% w/w

3. Pharmaceutical form

Cream

4. Clinical particulars
4.1 Therapeutic indications

Indications

(a)   First aid dressing for minor burns, scalds, abrasions and other open injuries and their routine treatment,

(b)   For the treatment of surface infections due to susceptible organisms, particularly in cases with penicillin resistant Staphylococci or certain Gram-negative bacilli.

(c)   Treatment of ringworm of the scalp (Microsporum canis) and other superficial fungal infections.

(d)   Treatment of pyodermias, including sycosis barbae.

(e)   Treatment of otitis externa.

(f)    Treatment of nappy rash.

4.2 Posology and method of administration

Adults: apply to the affected area, either directly or on a light dressing, two or three times a day.

Elderly and children: no specific recommendations.

4.3 Contraindications

Brulidine Cream should not be used in patients with known hypersensitivity to dibrompropamidine or any of the other ingredients

4.4 Special warnings and precautions for use

Prolonged use may interfere with healing and cause skin necrosis in infants.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

There is no evidence of the drug's safety in human use nor is there any evidence from animal work that it is free from hazard. Avoid unless considered essential.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

There is always the possibility, although rare, of a sensitisation reaction or contact dermatitis occurring: in such an event, treatment should be discontinued immediately.

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

The 25g tube of Brulidine Cream contains 37.5mg of dibrompropamidine, the 30g contains 45mg and the 50g contains 75mg. No toxic effects are likely to occur even if the contents of a full tube are accidentally ingested. Similarly, the ingredients of the base are unlikely to have toxic effects in the quantities present.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Dibrompropamidine isetionate is an antibacterial agent active against pathogenic Streptococci and Staphylococci, including penicillin resistant strains, and has some activity against a number of Gram negative bacilli. Its antibacterial action is not inhibited by pus, blood or p-aminobenzoic acid. In addition, it has useful activity against certain species of pathogenic fungi.

Brulidine Cream is well tolerated and rarely gives rise to sensitisation reactions or contact dermatitis.

5.2 Pharmacokinetic properties

No data available.

5.3 Preclinical safety data

No relevant data.

6. Pharmaceutical particulars
6.1 List of excipients

Castor oil, virgin

Cetostearyl alcohol

Polyethylene glycol 600 monostearate

Methyl parahydroxybenzoate

Silicone MS Antifoam A

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Collapsible aluminium internally lacquered tube with extended nozzle containing 25g, 30g or 50g cream. Polythene plug seal cap.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Tillomed Laboratories Limited

220 Butterfield

Great Marlings

Luton

LU2 8DL

United Kingdom

8. Marketing authorisation number(s)

PL 11311/0824

9. Date of first authorisation/renewal of the authorisation

1 September 1997/22 December 2010

10. Date of revision of the text

04/09/2025

Tillomed Laboratories Ltd
Company image
Address
220 Butterfield, Great Marlings, Luton, LU2 8DL, UK
Telephone
+44 (0)1480 402 400
Medical Information Direct Line
+44 (0)1480 402 400 [option 2]
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)1480 402 400 [option 1]
Stock Availability
+44 (0)1480 402 400 [option 1]
WWW
http://www.tillomed.com/