SOOLANTRA Cream Ref.[8175] Active ingredients: Ivermectin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK

Product name and form

Soolantra 10 mg/g cream.

Pharmaceutical Form

Cream.

White to pale yellow hydrophilic cream.

Qualitative and quantitative composition

One gram of cream contains 10 mg of ivermectin.

Excipient(s) with known effect: One gram of cream contains 35 mg of cetyl alcohol, 25 mg of stearyl alcohol, 2 mg of methyl parahydroxybenzoate (E218), 1 mg of propyl parahydroxybenzoate (E216) and 20 mg of propylene glycol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ivermectin

Ivermectin is a member of the avermectin class and has high affinity with glutamate-gated chloride channels present in invertebrate nerve and muscle cells. Its binding to these channels promotes an increase in membrane permeability to chloride ions, leading to hyperpolarization of the neural or muscle cell. This results in neuromuscular paralysis and may lead to the death of certain parasites.
List of Excipients

Glycerol
Isopropyl palmitate
Carbomer
Dimeticone
Disodium edetate
Citric acid monohydrate
Cetyl alcohol
Stearyl alcohol
Macrogol cetostearyl ether
Sorbitan stearate
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Phenoxyethanol
Propylene glycol
Oleyl alcohol
Sodium hydroxide
Purified water

Pack sizes and marketing

Polyethylene (PE)/Aluminium (Al)/ Polyethylene (PE) laminated plastic white tubes with:

  • A white high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure for the 15 g, 30 g, 45 g or 60 g tubes
  • A polypropylene (PP) white cap for the 2 g tubes (non child resistant closure)

Pack sizes: 1 tube of 2 g, 15 g, 30 g, 45 g or 60 g.

Not all pack sizes may be marketed.

Marketing authorization holder

Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK

Marketing authorization dates and numbers

PL 10590/0063

17/04/2015

Drugs

Drug Countries
SOOLANTRA Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Malta, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States
 
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