Patient Information Leaflet

Cetrimide Antiseptic First Aid Cream

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you need more information or advice, please ask your doctor or pharmacist.

•    You must contact a doctor if your symptoms get worse or do not improve.

•    If any side effect gets serious, or if you notice

any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you accidentally swallow this medicine

You should contact your doctor or go to your nearest hospital casualty department immediately.

Take the pack with you so that the doctor knows what you have swallowed.

4. Possible side effects

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you use this medicine

3.    How to use this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

1. What this medicine is and what it is used for

This medicine contains the active ingredient cetrimide. Cetrimide is an antiseptic which helps prevent infection in cuts, grazes, small wounds, nappy rash & chapped hands.

2. Before you use this medicine

Some people must not use this medicine.

Do not use this medicine if you are allergic to cetrimide or any of the other ingredients (these are all listed in section 6)

Other special warnings

This medicine contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and E214, E216 and E218 which may cause allergic reactions (possibly delayed).

Prolonged and repeated use is not advisable, as hypersensitivity (an allergic reaction) is more likely to occur. If your symptoms persist consult your doctor.

3. How to use this medicine

For external use only.

Avoid contact with the eyes.

For all ages:

For general use, clean the surrounding skin and apply the cream directly, or use a piece of clean lint or gauze to apply the cream.

Cetrimide is usually well tolerated, however, like all medicines it may sometimes cause side effects. Occasionally in some people it may cause a hypersensitivity reaction (an allergic reaction). If a skin rash or itching occurs stop using the cream and tell your doctor or pharmacist.

If you notice any other unwanted effects, please go and see your doctor or pharmacist.

5. How to store this medicine

Keep out of the reach and sight of children.

Do not use after the expiry date shown on the carton or tube.

6. Further information

Ingredients

This cream contains the active ingredient cetrimide 0.5% w/w. The other ingredients are cetostearyl alcohol, liquid paraffin, phenoxyethanol,

1-butyl 4-hydroxybenzoate, butyl parahydroxybenzoate, ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) & purified water.

What the medicine looks like

The medicine is a smooth white cream. It is available in packs containing 15g, 30g, 45g, 50g or 60g. Not all pack sizes may be available.

Product licence holder and manufacturer

The product licence holder is OTC Concepts Ltd., 2 Park Street, Woburn, Bedfordshire, MK17 9PG, UK. Manufactured by Thorpe Laboratories Ltd., Golf Road Industrial Estate, Mablethorpe, Lincolnshire, LN12 1NB, UK.

Product Licence Number:

PL 20338/0002

Date of leaflet preparation: March 2008.

If you would like this leaflet in a different format, please contact the licence holder at the above address.

This is the end of the leaflet.