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LOCERYL Nail lacquer (2019)

Active ingredients: Amorolfine

Product Name and Form

Loceryl 5% w/v Medicated Nail Lacquer.

Pharmaceutical form

Medicated Nail Lacquer.

Qualitative and Quantitative Composition

Loceryl nail lacquer contains 5% w/v amorolfine in the form of hydrochloride. Amorolfine is chemically described as cis-4-[(RS)3[4(1,1-Dimethylpropyl)phenyl]-2-methylpropyl]-2,6-dimethylmorpholine.

Amorolfine hydrochloride HSE 6.40 w/w.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Amorolfine

Amorolfine is a broad spectrum antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.

List of excipients

Ammonio methacrylate copolymer A
Triacetin
Butyl acetate
Ethyl acetate
Ethanol absolute

Pack sizes and Marketing

Amber glass type I bottle with screw thread and plastic screw closure.

Packs contain cleansing swabs, spatulas and nail files.

Or

Amber glass type III bottle with screw thread and plastic screw closure with integrated applicator.

Packs contain cleansing swabs and nail files.

Pack Sizes:

2.5 ml (1 × 2.5 ml)
5.0 ml (1 × 5.0 ml)
7.5 ml (1 × 2.5 ml & 1 × 5.0 ml)
10.0 ml (2 × 5.0 ml)

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

04/07/1991 / 09/01/1992

Marketing authorization number:

PL 10590/0042