Dermal Laboratories Limited

EXTEROL™ 5% w/w EAR DROPS, SOLUTION

Urea Hydrogen Peroxide 5.0% w/w.

For a full list of excipients, see section 6.1.

Ear drops, solution.

Clear, straw-coloured viscous solution.

As an aid in the removal of hardened ear wax.

For adults, children and the elderly. Instil up to 5 drops into the ear. Retain drops in ear for several minutes by keeping the head tilted and then wipe away any surplus. Repeat once or twice daily for at least 3 to 4 days, or as directed by the physician.

Do not use if the eardrum is known or suspected to be damaged, in cases of dizziness, or there is or has been any other ear disorder (such as pain, discharge, inflammation, infection or tinnitus). Do not use within 2 to 3 days of syringing or after ill-advised attempts to dislodge wax using fingernails, cotton buds or similar implements, as such mechanical efforts can cause the ear's delicate inner lining to become damaged, inflamed or infected, whereupon the use of ear drops can be painful. Do not use where there is a history of ear problems, unless instructed to do so by a doctor. Do not use if sensitive to any of the ingredients.

Keep Exterol away from the eyes. Keep out of the reach of children. For external use only. Replace cap after use, and return bottle to carton.

Exterol should not be used at the same time as any other type of topical preparation in the ear.

No known side-effects.

None known.

Due to the release of oxygen, patients may experience a mild, temporary effervescence in the ear. Stop usage if irritation or pain occurs. Instillation of ear drops can aggravate the painful symptoms of excessive ear wax, including some loss of hearing, dizziness and tinnitus. Very rarely, blurred vision and unpleasant taste have been reported. If patients encounter any of these problems, or if their symptoms persist or worsen, they should discontinue treatment and consult a doctor.

No adverse effects.

After insertion of the drops into the ear, the urea hydrogen peroxide complex liberates oxygen which acts to break up the hardened wax. The hydrogen peroxide component is also a cerumenolytic. Its action as an antiseptic, especially in sites with relative anaerobiosis is well known. The glycerol and urea assist in softening the wax, so that it may more easily be removed from the ear, either with or without syringing. The urea acts as a mild keratolytic, helping to reduce the keratin-load in the wax debris, thereby assisting penetration of the other components.

Exterol is intended only for the treatment of impacted wax in the external auditory canal. The ingredients of the formulation are therefore readily available for intimate contact with the affected area, as the drops are instilled into the ear and retained therein for several minutes by tilting the head.

No special information.

8-Hydroxyquinoline; Glycerol.

Do not use concurrently with anything else in the ear.

24 months.

Discard 4 weeks after first opening.

Store upright. Do not store above 25°C. Keep the bottle tightly closed. Keep the bottle in the outer carton.

8 ml easy squeeze plastic dropper bottle with screw cap.

No special requirements.

Dermal Laboratories Limited

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

PA 278/9/1.

28 January 2007.

January 2007.