XYLOPROCT Ointment Ref.[50625] Active ingredients: Hydrocortisone Lidocaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Xyloproct 5%/0.275% Ointment.

Pharmaceutical Form

Ointment.

Qualitative and quantitative composition

Composition for: 100 g:

Lidocaine 5 g

Hydrocortisone Acetate micro Ph. Eur. 0.275 g

Excipients with known effect:

Cetyl alcohol (7.4 g per 100 g of ointment)
Stearyl alcohol (0.9 g per 100 g of ointment)

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.

Lidocaine

Lidocaine, like other local anaesthetics, causes a reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ions through the nerve membrane. Local anaesthetics of the amide-type are thought to act within the sodium channels of the nerve membrane.

List of Excipients

Zinc oxide
Aluminium acetate
Stearyl alcohol
Cetyl alcohol
Water purified
Macrogol (3350 and 400)

Pack sizes and marketing

Aluminium tube 20 g.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PL 39699/0087

Date of first authorisation: 22 February 1972
Date of latest renewal: 03 April 2003

Drugs

Drug Countries
XYLOPROCT Brazil, Mexico, United Kingdom

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