DAKTARIN Oral gel Ref.[6990] Active ingredients: Miconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Product name and form


Pharmaceutical Form

Oral gel.

White gel with orange taste.

Qualitative and quantitative composition

Each gram of Daktarin Oral Gel contains 20 mg of miconazole.

Excipients with known effect: Alcohol 7.59 mg/g.

For the full list of excipients, see 6.1.

Active Ingredient Description

Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.

List of Excipients

Purified water
Pregelatinised potato starch
Polysorbate 20
Sodium saccharin
Cocoa flavour
Orange flavour

Pack sizes and marketing

Aluminium tubes containing 5g*, 15g*, 30g* 40g* or 80g gel.

A 5 ml plastic spoon, marked with a 2.5 ml graduation is provided.

* not marketed

Marketing authorization holder

Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Marketing authorization dates and numbers

PL 00242/0048

Date of First Authorisation: 19 July 1977
Date of Renewal of Authorisation: 22 May 2008


Drug Countries
DAKTARIN Austria, Australia, Brazil, Cyprus, Germany, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, South Africa

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