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

Product name and form

Exterol 5% w/w Ear Drops, Solution.

Pharmaceutical Form

Ear drops, solution.

Clear, straw coloured viscous ear drops.

Qualitative and quantitative composition

Urea Hydrogen Peroxide 5.0% w/w.

For excipients see 6.1.

Active Ingredient Description
Urea

Urea is a recognised hydrating agent that has been widely used topically to treat dry or damaged skin.

List of Excipients

8-Hydroxyquinoline
Glycerol

Pack sizes and marketing

a) 12 ml amber glass BOTTLE incorporating a specially designed polythene pipette APPLICATOR enclosed in a polypropylene SCREW CAP.

b) 15 ml low density polyethylene BOTTLE with low density polyethylene nozzle APPLICATOR and tamper-evident SCREW CAP.*

c) 5 ml low density polyethylene BOTTLE with low density polyethylene nozzle APPLICATOR and tamper-evident SCREW CAP.*

* Plus intervening BOTTLE capacities within the range 5 ml to 15 ml, all of exactly the same material.

Supplied as original packs (OP).

Marketing authorization holder

Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire, SG4 7QR

Marketing authorization dates and numbers

PL 00173/0037

26 February 1982 / 28 January 2007 (unlimited validity)

Drugs

Drug Countries
EXTEROL Ireland, Israel, United Kingdom

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