PACKAGING LEAFLET: INFORMATION FOR THE USER DETTOL MED 4.8% w/w CONCENTRATE for CUTANEOUS SOLUTION (Chloroxylenol)

FOR EXTERNAL USE ONLY

Important information about the ingredients of Dettol Med Concentrate for Cutaneous Solution

This product contains Chloroxylenol 4.8% w/w as the active ingredient which may cause skin irritation.

It must be diluted with water before use.

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Dettol Med Concentrate for Cutaneous Solution carefully to get the best results from it.

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

-    Ask your pharmacist if you need more information or advice.

-    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Dettol Med Concentrate for Cutaneous Solution is and what it is used for

2.    Before you use Dettol Med Concentrate for Cutaneous Solution

3.    How to use Dettol Med Concentrate for Cutaneous Solution

4.    Possible side effects

5.    How to store Dettol Med Concentrate

6.    Further information

1.    WHAT DETTOL MED CONCENTRATE for CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR

Dettol Med Cutaneous Concentrate, which after diluting in water to produce a milky solution, is a topical antiseptic used for cleansing of minor wounds such as cuts, grazes and insect bites and stings.

It is in concentrated form and requires dilution before use.

Do not use Dettol Med Concentrate for Cutaneous Solution undiluted.

2.    BEFORE YOU USE DETTOL MED CONCENTRATE for CUTANEOUS SOLUTION

Do not use on infants under 12 months of age.

Do not use Dettol

•    If you have Eczema (a dry scaly skin condition)

•    If you are allergic or hypersensitive to Chloroxylenol or any of the other ingredients of Dettol Med Concentrate for Cutaneous Solution.

Do not use around the eyes, ears, nose or mouth.

If swallowed, wash out the mouth and drink plenty of water or milk. In the case of accidental eye contact, the eye should be washed with copious amounts of cold water. In both case a doctor should be consulted.

If used undiluted, wash off the skin and consult a doctor if a skin reaction occurs.

Using other medicines

Since no specific studies have been done we cannot recommend the use of Dettol Med Concentrate for Cutaneous Solution with any other topical product.

Pregnancy and Breast feeding

Dettol Med Concentrate for Cutaneous Solution can be used during pregnancy under medical supervision. It is not recommend to apply Dettol to the skin of the breast during breast feeding.

Driving and using machines

Dettol Med Concentrate for Cutaneous Solution will not affect your ability to drive or operate machines.

3.    HOW TO USE DETTOL MED CONCENTRATE FOR CUTANEOUS SOLUTION

For use on skin only.

Cuts, bites, abrasions and insect stings - Dilute 50mls Dettol Med concentrate to 1 litre with water (a 1 in 20 dilution) and wash the affected area with this solution. Cover with a dry gauze or lint.

For adults and children over 12 months of age.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Dettol Med Concentrate for Cutaneous Solution can cause side effects, although not everybody gets them. These are very rare (affects less than 1 in 100000 people).

Skin reactions have occurred when used to cleanse skin wounds such as irritation, rashes, progressive degeneration of the skin, skin sores at the site of application. Inflammation, skin discolouration, itching, skin scaling and peeling and a burning sensation. Hair loss has also been reported.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your Doctor or Pharmacist.

5. HOW TO STORE DETTOL MED CONCENTRATE FOR CUTANEOUS SOLUTION

Keep out of the reach and sight of children.

Do not use Dettol Med Concentrate for Cutaneous Solution after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Once diluted the solution should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Dettol Med Concentrate for Cutaneous Solution contains

- The active substance is Chloroxylenol 4.8mg/100ml concentrate for cutaneous solution.

- The other ingredients are Pine oil, isopropyl alcohol, castor oil soap, caramel (E150c) and purified water

What Dettol Med Concentrate for Cutaneous Solution looks like and contents of the pack

Dettol Med Concentrate for Cutaneous Solution is a clear amber liquid. Once diluted in water it becomes a milky white solution. It is available in bottles of 125ml, 250ml, 500ml, 750ml, 1000ml and 1250ml.(Not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

MA holder: Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough, SL1 3UH United Kingdom

Manufacturer: Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS.

This leaflet was last approved in 02/2013

This medicinal product is authorised in the Member States of the EEA under the following names: _

Name of Member state	Name of Medicine
Belgium	Dettolmedical Chloroxylenol 4.8%
Czech Republic	Dettolmedicinal Chloroxylenol 48mg/ml
Slovak Republic	Dettol Med
Norway	Dettomed
Finland	Dettolmed
Ireland	Dettol Med
Sweden	Dettolmed
Poland	Dettol Med
France	Dettollinn
Netherlands	Dettol Med Chloroxylenol
Portugal	Detmed
Slovenia	Dettol Med
Luxembourg	Dettolmedical Chloroxylenol 4.8%