LOTRIDERM Cream Ref.[50612] Active ingredients: Betamethasone Clotrimazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Product name and form

LOTRIDERM 0.05% w/w /1.0% w/w Cream.

Pharmaceutical Form

Cream.

Smooth, uniform, white to off-white cream.

Qualitative and quantitative composition

Betamethasone dipropionate 0.064% w/w* (* equivalent to 0.05% betamethasone)
Clotrimazole 1.0% w/w

Excipients with known effect:

Cetostearyl alcohol,
Propylene glycol, 100mg/g of cream
Benzyl alcohol, 10mg/g of cream

For the full list of excipients, see section 6.1.

Active Ingredient Description
Betamethasone

Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. Betamethasone has anti-inflammatory, antipruritic, and vasoconstrictive properties.

Clotrimazole

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

List of Excipients

Liquid paraffin
White soft paraffin
Cetostearyl alcohol
Macrogol cetostearyl ether
Benzyl alcohol
Sodium dihydrogen phosphate dihydrate
Phosphoric acid concentrated
Sodium hydroxide
Propylene glycol (E 1520)
Purified water

Pack sizes and marketing

The product will be marketed in standard epoxy-lined aluminium tubes with low density polyethylene caps. Tubes will contain 2g or 5g (Professional Sample Packs), 15g, 30g or 50g.

Not all pack sizes may be marketed.

Marketing authorization holder

Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization dates and numbers

PL 00025/0568

October 1992 / July 2007

Drugs

Drug Countries
LOTRIDERM Canada, Ecuador, Poland, United Kingdom, South Africa

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