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

Product name and form

Daktarin Intensiv Cream.

Pharmaceutical Form

Cream.

White homogenous cream.

Qualitative and quantitative composition

Ketoconazole 2% w/w.

Excipients include: propylene glycol, stearyl alcohol, cetyl alcohol.

For full list of excipients, see section 6.1.

Active Ingredient Description
Ketoconazole

Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes.

Miconazole

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

Propylene glycol
Stearyl alcohol
Cetyl alcohol
Sorbitan stearate
Polysorbate 60
Isopropyl myristate
Sodium sulphite anhydrous (E221)
Polysorbate 80
Purified water

Pack sizes and marketing

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.

Marketing authorization holder

McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, United Kingdom

Marketing authorization dates and numbers

PL 15513/0181

16/12/2009

Drugs

Drug Countries
DAKTARIN INTENSIV United Kingdom

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