NERISONE Cream, Ointment Ref.[27952] Active ingredients: Diflucortolone

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: LEO Pharma Limited, Auckland, New Zealand, Toll Free No.: 0800 497 456

Product name and form

NERISONE Diflucortolone valerate 0.1% fatty ointment.

NERISONE Diflucortolone valerate 0.1% cream.

Pharmaceutical Form

Topical cream.

Topical fatty ointment.

Qualitative and quantitative composition

NERISONE Cream: 1 g white cream contains 1 mg (0.1%) diflucortolone valerate. The cream is an oil-in-water emulsion containing approximately 70% water.

NERISONE Fatty Ointment: 1 g white single-phase fatty ointment contains 1 mg (0.1%) diflucortolone valerate. NERISONE Fatty Ointment contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

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.

List of Excipients

Cream: White soft paraffin, liquid paraffin, stearyl-alcohol, polyoxyl 40 stearate, polyacrylic acid, sodium hydroxide, disodium edetate dihydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Fatty Ointment: White soft paraffin, liquid paraffin, microcrystalline wax, hydrogenated castor oil.

Pack sizes and marketing

Tubes 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

LEO Pharma Limited, Auckland, New Zealand, Toll Free No.: 0800 497 456

Marketing authorization dates and numbers

June 1976

Drugs

Drug Countries
NERISONE Germany, France, Hong Kong, New Zealand, United Kingdom, South Africa

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