Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4 EG, UK
Daktacort 2% / 1% w/w cream.
| Pharmaceutical Form |
|---|
|
White, homogeneous cream. |
Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.
Excipients with known effect:
Daktacort contains 2 mg/g benzoic acid (E210).
5 g: This medicine contains 10 mg benzoic acid in each tube of 5 g cream which is equivalent to 2 mg/g cream.
10 g: This medicine contains 20 mg benzoic acid in each tube of 10 g cream which is equivalent to 2 mg/g cream.
15 g: This medicine contains 30 mg benzoic acid in each tube of 15 g cream which is equivalent to 2 mg/g cream.
30 g: This medicine contains 60 mg benzoic acid in each tube of 30 g cream which is equivalent to 2 mg/g cream.
75 g: This medicine contains 150 mg benzoic acid in each tube of 75 g cream which is equivalent to 2 mg/g cream.
Daktacort contains 0.052 mg/g butylated hydroxyanisole (E320).
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hydrocortisone |
Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. |
|
| 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 |
|---|
|
PEG-6, PEG-32 and glycol stearate |
Aluminium tube with polypropylene cap.
Each tube contains 5 g, 10 g, 15 g, 30 g or 75 g cream.
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4 EG, UK
PL 00242/0042
Date of first authorisation: 04/02/77
Renewal of authorisation: 24/02/2009
| Drug | Countries | |
|---|---|---|
| DAKTACORT | Cyprus, Finland, Hong Kong, Ireland, Israel, Malta, Netherlands, Singapore, United Kingdom, South Africa |
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