LOCOID Cream Ref.[27966] Active ingredients: Hydrocortisone butyrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Product name and form

Locoid cream.

Pharmaceutical Form

Cream.

White cream.

Qualitative and quantitative composition

1 gram of Locoid Cream contains 1 mg of hydrocortisone butyrate.

Excipient(s) with known effect: Cetostearyl alcohol (7.2% w/w), Butyl parahydroxybenzoate (0.05% w/w), Propyl parahydroxybenzoate (0.1% w/w)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Hydrocortisone butyrate

Hydrocortisone butyrate is the butyrate salt form of hydrocortisone, a synthetic glucocorticoid receptor agonist with antiinflammatory, antipruritic and vasoconstrictive effects. Binding and activation of the glucocorticoid receptor results in the activation of lipocortin that in turn inhibits cytosolic phospholipase A2.

List of Excipients

Cetostearyl alcohol
Macrogol 25 Cetostearyl ether
Paraffin, light liquid
White Soft Paraffin
Butyl parahydroxybenzoate
Propyl parahydroxybenzoate (E216)
Citric Acid anhydrous (E330)
Sodium Citrate anhydrous (E331)
Purified Water

Pack sizes and marketing

Collapsible aluminium tubes containing either 30 g, 50 g, 100 g or 200 g packed in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Marketing authorization dates and numbers

PL 05293/0010

Date of first authorisation: 28 September 1973
Date of latest renewal: 24 August 2010

Drugs

Drug Countries
LOCOID Finland, France, Ireland, Japan, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States, South Africa

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