FLUTICASONE PROPIONATE Cream Ref.[6857] Active ingredients: Fluticasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Product name and form

Fluticasone Propionate 0.05% cream.

Pharmaceutical Form

Cream.

White, viscous and homogeneous cream.

Qualitative and quantitative composition

Each 100g of cream contains: Fluticasone propionate 0.05g.

Excipients with known effect:

Cetostearyl alcohol 5.25 g

Imidurea 0.20 g

Propylene glycol 10.00 g

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluticasone

Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

List of Excipients

Macrogol cetostearyl ether
Cetostearyl alcohol
Isopropyl myristate
Paraffinum liquidum
Purified water
Propylene glycol
Citric acid monohydrate
Disodium phosphate anhydrous
Imidazolinyl urea

Pack sizes and marketing

30g of cream contained in an aluminium tube with white high-density polypropylene screw cap.

Marketing authorization holder

Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization dates and numbers

PL35533/0131

31/10/2012

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