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LOCERYL NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE

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VAR.# 7 - add 'Laboratoires Galderma, France' as new manufacturer
Approved by H.Udani on 26.06.08
MOCK UP

VAR # 5 - update labelling text and add braille
Approved by H.Udani on 25.6.08
MOK UP braille labels
®

DRUG NAME: LOCERYL NAIL LACQUER
THE OUTER LABEL WILL INCLUDE THE FOLLOWING TEXT:
POM
Loceryl® Nail Lacquer 5%
(amorolfine)
5ml
Contains 5% w/v amorolfine in the form of the hydrochloride
Excipients include methacrylic acid copolymer, triacetin, butyl acetate, ethyl acetate and ethanol.
Also contains nail files, application spatulas and cleaning swabs.
Use only as directed by a physician
Apply to the nails
Read the enclosed leaflet before use.
For external use only
Keep out of the reach and sight of children
Store below 30°C. Protect from heat. Keep bottle firmly closed after use.
Manufactured by: LABORATOIRES GALDERMA, Alby–sur-Chéran, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR
PL No: 04423/0392
ECMA No: 29717/92/09.02.93
24581/3-5-2004
Exp:
Lot:
Loceryl® is a registered trademark of Galderma S.A.
Text for bottle label
Loceryl® Nail Lacquer 5%
(amorolfine)
5ml
For external use only
Apply to the nails
Lot:
Exp:
PL holder: Doncaster Pharmaceuticals Group Ltd, DN3 1QR.
BRAILLE LABEL
Overlabelling: To appear on rear face over our outer carton label.
Marburg Medium will be used as recommended by RNIB.
I can confirm that the label will only appear only on one face of the carton and that the underlying text will
be easily legible.
Imported braille is incorrect, so this will be obscured with a blank label.

Loceryl nail
lacquer #e 3p

Date: 11.06.08

Neerja Mittal

Translates to: loceryl nail lacquer 5 %
Measurements: BR21 - 95 mm x 37 mm

Replace page dated: 18.04.08

DRUG NAME: AMOROLFINE HYDROCHLORIDE NAIL LACQUER 5%
THE OUTER LABEL WILL INCLUDE THE FOLLOWING TEXT:
POM
Amorolfine Hydrochloride Nail Lacquer 5%
(amorolfine)
5ml
Contains 5% w/v amorolfine in the form of the hydrochloride
Excipients include methacrylic acid copolymer, triacetin, butyl acetate, ethyl acetate and ethanol.
Also contains nail files, application spatulas and cleaning swabs.
Use only as directed by a physician
Apply to the nails
Read the enclosed leaflet before use.
For external use only
Keep out of the reach and sight of children
Store below 30°C. Protect from heat. Keep bottle firmly closed after use.
Manufactured by: LABORATOIRES GALDERMA, Alby – Sur Chéran, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR
PL No: 04423/0392
ECMA No: 29717/92/09.02.93
24581/3-5-2004
Exp:
Lot:
Text for bottle label
Amorolfine Hydrochloride Nail Lacquer 5%
(amorolfine)
5ml
For external use only
Apply to the nails
Lot:
Exp:
PL holder: Doncaster Pharmaceuticals Group Ltd, DN3 1QR.
BRAILLE LABEL
Overlabelling: To appear on rear face over our outer carton label.
Marburg Medium will be used as recommended by RNIB.
I can confirm that the label will only appear only on one face of the carton and that the underlying text will
be easily legible.
Imported braille is incorrect, so this will be obscured with a blank label..
Translates to: amorolfine hydrochloride nail lacquer 5%
Measurements: BR40 – 100 mm x 45 mm

amorolfine
hydrochloride
nail lacquer
#e 3p
Date: 11.06.08

Neerja Mittal

Replace page dated: 18.04.08

VAR # 4 -add ECMA 24581/3.5.2004 Approved by H.Udani 9.6.08
MOCK UP

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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