DAKTARIN INTENSIV Cream Ref.[6931] Active ingredients: Ketoconazole Miconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, United Kingdom

Therapeutic indications

For the treatment of the following mycotic infections of the skin: tinea pedis and tinea cruris.

Posology and method of administration

Ketoconazole cream is for use in adults.

For the treatment of tinea pedis (athlete’s foot) and tinea cruris (dhobie itch).

Tinea cruris and tinea pedis: It is recommended that Daktarin Intensiv Cream be applied once or twice daily to cover the affected and immediate surrounding area.

The usual duration of treatment is tinea cruris 2-4 weeks, tinea pedis 4-6 weeks.

Treatment should be continued, until a few days after disappearance of all symptoms. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks of treatment.

Method of administration

Topical administration.

Paediatric patients

The safety and efficacy of Daktarin Intensiv Cream in children (17 years and younger) has not been established.

Overdose

Topical application.

Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.

In the event of accidental ingestion, supportive and symptomatic measures should be carried out.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Tube made of 99.7% aluminum, lined on inner side with heat polymerised epoxyphenol resin with a latex coldseal ring at the end of the tube. The cap is made of 60% polypropylene, 30% calcium carbonate and 10% glyceryl monostearate.

Tubes of 5, 15 and 30g.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Any unused medicinal products or waste material should be disposed of in accordance with local requirements.

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