Brulidine 0.15 %w/w Cream

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.

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.

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

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

None known.

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.

None.

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.

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.

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.

No data available.

No relevant data.

Castor oil, virgin

Cetostearyl alcohol

Polyethylene glycol 600 monostearate

Methyl parahydroxybenzoate

Silicone MS Antifoam A

Purified water

Not applicable.

36 months.

Store below 25°C.

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

Not applicable.