EXTEROL Ear drops, solution Ref.[49929] Active ingredients: Urea

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire, SG4 7QR

5.1. Pharmacodynamic properties

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 an antiseptic, especially in sites with relative anaerobiosis. The glycerol assists 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.

5.2. Pharmacokinetic properties

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.

5.3. Preclinical safety data

No special information.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.