CANDIPLAS H Cream Ref.[28051] Active ingredients: Hydrocortisone Miconazole

Source: Υπουργείο Υγείας (CY)  Revision Year: 2017  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Candiplas H 2%w/w / 1%w/w cream.

Pharmaceutical Form

Cream.

White, soft, homogeneous, smooth, odourless cream.

Qualitative and quantitative composition

Each 1 g of cream contains miconazole nitrate 2% w/w, equivalent to 20 mg, and hydrocortisone 1% w/w, equivalent to 10 mg.

Excipients with known effect:

  • Cetostearyl alcohol. Each 1 g of Candiplas H cream contains 77 mg cetostearyl alcohol.
  • Chlorocresol. Each 1g of Candiplas H cream contains 1 mg chlorocresol.

For the 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

Candiplas H cream also contains:

Purified water
Chlorocresol
Cetomacrogol 1000
Cetostearyl alcohol
White petrolatum
Liquid paraffin

Pack sizes and marketing

Lacquered collapsible aluminium tubes, crimped at bottom and sealed with a polypropylene screw cap containing 15 g and 30g of cream packed in a carton box.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

12705

Date of first authorization: 13/03/1990
Date of latest renewal: 18/09/2007

Drugs

Drug Countries
CANDIPLAS H Cyprus, Hong Kong, Malta

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