Sudosalve Nappy Rash Treatment 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 Gramnegative 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.

For cutaneous use.

Sudosalve nappy rash treatment 0.15%w/w 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.

This medicine contains the following excipients:

• Methyl parahydroxybenzoate (E218) may cause allergic reactions (possibly delayed)

• Castor oil may cause skin reactions

• Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

The 25g tube of Sudosalve nappy rash treatment 0.15%w/w 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.

ATC code: D08AC01

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-aminabenzoic acid. In addition, it has useful activity against certain species of pathogenic fungi. Sudosalve nappy rash treatment 0.15%w/w 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.