TRAVOCORT Cream Ref.[8251] Active ingredients: Diflucortolone Isoconazole

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Product name and form

Travocort 0.1 + 1% w/w Cream.

Pharmaceutical Form

Cream.

A white to yellowish opaque cream.

Qualitative and quantitative composition

Contains 0.1% w/w diflucortolone valerate (1mg/g) and 1% w/w isoconazole nitrate (10mg/g).

Excipient with known effect: cetostearyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Diflucortolone

Diflucortolone is a topically acting fluoridated corticosteroid which suppresses inflammation in inflammatory and allergic skin conditions and alleviates the subjective complaints such as itching, burning and pain.

Isoconazole

Isoconazole is for use in the treatment of superficial fungal diseases of the skin. It displays a very broad spectrum of antimicrobial action. It is effective against dermatophytes and yeasts, yeast-like fungi (including the causative organism of pityriasis versicolor) and molds, as well against gram-positive bacteria in-vitro and against the causative organism of erythrasma.

List of Excipients

Paraffin, white soft
Paraffin, liquid
Cetostearyl alcohol
Polysorbate 60
Sorbitan stearate
Disodium edetate dihydrate
Water, purified

Pack sizes and marketing

Tube with 15 g made of pure aluminium, interior wall coated with epoxy resin, and with a polyester-based external coating, fold seal ring is made of polyamide based heat sealable material. The screw cap is made of high density polyethylene.

Marketing authorization holder

Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Marketing authorization dates and numbers

PA1410/073/001

Date of first authorisation: 27 March 1981
Date of last renewal: 27 March 2006

Drugs

Drug Countries
TRAVOCORT Austria, Cyprus, Estonia, Hong Kong, Croatia, Ireland, Lithuania, Malta, Poland, Romania, Singapore, Turkey, South Africa

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