TEOPTIC 1% EYE DROPS

Active substance: CARTEOLOL HYDROCHLORIDE

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By laurentj at 3:29 pm, 12/12/06

CARTON TEXT LABEL
5ml

TEOPTIC® 1% EYE DROPS
(carteolol hydrochloride)

Each ml of Sterile Eye Drops Solution contains 10mg carteolol hydrochloride
Also contains: sodium phosphate, sodium acid phosphate, sodium chloride, benzalkonium chloride
and sterile purified water

FOR EXTERNAL USE ONLY
Read enclosed leaflet before use. To be instilled into the affected eye (s) as directed by your doctor.

Do not wear soft contact lenses while using these eye drops.
DO NOT STORE ABOVE 25°C. DO NOT ACCEPT FOR INITIAL USE IF THE SEAL IS BROKEN.
DISCARD THE CONTENTS 28 DAYS AFTER FIRST OPENING THE BOTTLE.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
BATCH NO: 1234567/8
PL NO: 10383/1005

EXPIRY: DD/MM/YYYY
ECMA NO: 991372

POM
Manufactured by Laboratoire Chauvin S.A, le Millenard BP. 1174 Montpeiller, 34009 Cedex France
Procured from within the EU by the PL Holder: Primecrown Ltd., 28, Sarum Complex, Uxbridge,
Middlesex UB8 2RZ

Braille Mock Up to be applied as over-label

Teoptic
#1%

By hunjunts at 11:55 am, 1/10/07

I give assurance that Braille will not obscure any statutory information and will conform to the Marburg
medium specification. The existing Braille will also be completely obscured.

Date: 29.11.2006

Sign: Joel

CARTON TEXT LABEL
5ml

MIKELAN 1% EYE DROPS
(carteolol hydrochloride)

Each ml of Sterile Eye Drops Solution contains 10mg carteolol hydrochloride
Also contains: sodium phosphate, sodium acid phosphate, sodium chloride, benzalkonium chloride
and sterile purified water

FOR EXTERNAL USE ONLY
Read enclosed leaflet before use. To be instilled into the affected eye (s) as directed by your doctor.

Do not wear soft contact lenses while using these eye drops.
DO NOT STORE ABOVE 25°C. DO NOT ACCEPT FOR INITIAL USE IF THE SEAL IS BROKEN.
DISCARD THE CONTENTS 28 DAYS AFTER FIRST OPENING THE BOTTLE.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
BATCH NO: 1234567/8
PL NO: 10383/1005

EXPIRY: DD/MM/YYYY
ECMA NO: 991372

POM
Manufactured by Laboratoire Chauvin S.A, le Millenard BP. 1174 Montpeiller, 34009 Cedex France
Procured from within the EU by the PL Holder: Primecrown Ltd., 28, Sarum Complex, Uxbridge,
Middlesex UB8 2RZ

Braille Text to be applied as over-label

Mikelan
#1%

By hunjunts at 11:56 am, 1/10/07

I give assurance that Braille will not obscure any statutory information and will conform to the Marburg
medium specification. The existing Braille will also be completely obscured.

Date: 29.11.2006

Sign: Joel

CARTON TEXT LABEL
5ml

CARTEOLOL HYDROCHLORIDE 1% EYE DROPS

Each ml of Sterile Eye Drops Solution contains 10mg carteolol hydrochloride
Also contains: sodium phosphate, sodium acid phosphate, sodium chloride, benzalkonium chloride
and sterile purified water
FOR EXTERNAL USE ONLY
Read enclosed leaflet before use. To be instilled into the affected eye (s) as directed by your doctor.

Do not wear soft contact lenses while using these eye drops.
DO NOT STORE ABOVE 25°C. DO NOT ACCEPT FOR INITIAL USE IF THE SEAL IS BROKEN.
DISCARD THE CONTENTS 28 DAYS AFTER FIRST OPENING THE BOTTLE.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
BATCH NO: 1234567/8
PL NO: 10383/1005

EXPIRY: DD/MM/YYYY
ECMA NO: 991372

POM
Manufactured by Laboratoire Chauvin S.A, le Millenard BP. 1174 Montpeiller, 34009 Cedex France
Procured from within the EU by the PL Holder: Primecrown Ltd., 28, Sarum Complex, Uxbridge,
Middlesex UB8 2RZ

Braille Mock Up to be applied as over-label

Carteolol
Hydrochloride
#1%

The area of the panel of the carton is 2.5cmx8cm
and the submitted label is too large.

I give assurance that Braille will not obscure any statutory information and will conform to the Marburg
medium specification. The existing Braille will also be completely obscured.

Date: 29.11.2006

Sign: Joel

BOTTLE TEXT LABEL
5ml TEOPTIC 1% EYE DROPS
(carteolol hydrochloride)
Each ml of Sterile Eye Drops Solution contains 10mg carteolol hydrochloride
POM
To be instilled into the affected eye (s) as directed by your doctor.
BATCH NO: 1234567/8 EXPIRY: DD/MM/YYYY
PL NO: 10383/1005
ECMA NO: 991372
Primecrown Ltd., 28, Sarum Complex, Uxbridge, Middlesex UB8 2RZ

BOTTLE TEXT LABEL
5ml MIKELAN 1% EYE DROPS
(carteolol hydrochloride)
Each ml of Sterile Eye Drops Solution contains 10mg carteolol hydrochloride
POM
To be instilled into the affected eye (s) as directed by your doctor.
BATCH NO: 1234567/8 EXPIRY: DD/MM/YYYY
PL NO: 10383/1005
ECMA NO: 991372
Primecrown Ltd., 28, Sarum Complex, Uxbridge, Middlesex UB8 2RZ

BOTTLE TEXT LABEL
5ml

CARTEOLOL HYDROCHLORIDE 1% EYE DROPS

Each ml of Sterile Eye Drops Solution contains 10mg carteolol hydrochloride
To be instilled into the affected eye (s) as directed by your doctor.
POM
BATCH NO: 1234567/8 EXPIRY: DD/MM/YYYY
PL NO: 10383/1005
ECMA NO: 991372
Primecrown Ltd., 28, Sarum Complex, Uxbridge, Middlesex UB8 2RZ

Date: 29.11.2006

Sign: Joel

MOCK UP LABEL FOR TEOPTIC 1% EYE DROPS PL 10383/1005
5ml TEOPTIC® 1% EYE DROPS (carteolol hydrochloride)
Each ml of sterile eye drops solution contains 10mg carteolol hydrochloride. Also
contains: sodium phosphate, sodium acid phosphate, sodium chloride, benzalkonium
chloride and sterile purified water
To be instilled into the affected eye (s) as directed by your doctor.
Do not wear soft contact lenses while using these eye drops.
Do not store above 25°C. Do not accept for initial use if the seal is broken. Discard
the contents 28 days after first opening the bottle.
Read enclosed leaflet before use.
Keep all medicines out of the reach and sight of children. POM
FOR EXTERNAL USE ONLY
BN: 1234567/8
EXP: DD/MM/YYYY
PL: 10383/1005
ECMA: 991372
Manufactured by Laboratoire Chauvin S.A, Cedex France
Trademark Holder: Otsuka Pharmaceuticals Co., Ltd Japan.
Procured from within the EU by the PL Holder: Primecrown Ltd., 28, Sarum
Complex, Uxbridge, Middlesex UB8 2RZ

5ml MIKELAN® 1% EYE DROPS (carteolol hydrochloride)
Each ml of sterile eye drops solution contains 10mg carteolol hydrochloride. Also
contains: sodium phosphate, sodium acid phosphate, sodium chloride, benzalkonium
chloride and sterile purified water
To be instilled into the affected eye (s) as directed by your doctor.
Do not wear soft contact lenses while using these eye drops.
Do not store above 25°C. Do not accept for initial use if the seal is broken. Discard
the contents 28 days after first opening the bottle.
Read enclosed leaflet before use.
Keep all medicines out of the reach and sight of children. POM
FOR EXTERNAL USE ONLY
BN: 1234567/8
EXP: DD/MM/YYYY
PL 10383/1005
ECMA: 991372
Manufactured by: Laboratoire Chauvin S.A, Cedex France
Trademark Holder: Otsuka Pharmaceuticals Co., Ltd Japan.
Procured from within the EU by the PL Holder: Primecrown Ltd., 28, Sarum
Complex, Uxbridge, Middlesex UB8 2RZ

5ml TEOPTIC 1% EYE DROPS
(Carteolol hydrochloride)
Each ml of sterile eye drops solution contains 10mg carteolol
hydrochloride. To be instilled into the affected eye (s) as directed by
your doctor.
BN: 1234567/8 EXP: DD/MM/YYYY POM
PL 10383/1005 ECMA: 991372
Primecrown Ltd. 28, Sarum Complex, Uxbridge, Middx UB8 2RZ

5ml CARTEOLOL HYDROCHLORIDE 1% EYE DROPS
Each ml of sterile eye drops solution contains 10mg carteolol
hydrochloride. To be instilled into the affected eye (s) as directed by
your doctor.
BN: 1234567/8 EXP: DD/MM/YYYY POM
PL 10383/1005 ECMA: 991372
Primecrown Ltd. 28, Sarum Complex, Uxbridge, Middx UB8 2RZ

5ml MIKELAN 1% EYE DROPS
(Carteolol hydrochloride)
Each ml of sterile eye drops solution contains 10mg carteolol
hydrochloride. To be instilled into the affected eye (s) as
directed by your doctor.
BN: 1234567/8 EXP: DD/MM/YYYY POM
PL 10383/1005 ECMA: 991372
Primecrown Ltd. 28, Sarum Complex, Uxbridge, Middx UB8 2RZ

By hunjunts at 11:58 am, 1/10/07

5ml CARTEOLOL HYDROCHLORIDE 1% EYE DROPS
Each ml of sterile eye drops solution contains 10mg carteolol hydrochloride. Also
contains: sodium phosphate, sodium acid phosphate, sodium chloride, benzalkonium
chloride and sterile purified water
To be instilled into the affected eye (s) as directed by your doctor.
Do not wear soft contact lenses while using these eye drops.
Do not store above 25°C. Do not accept for initial use if the seal is broken. Discard
the contents 28 days after first opening the bottle.
Read enclosed leaflet before use.
Keep all medicines out of the reach and sight of children. POM
FOR EXTERNAL USE ONLY
BN: 1234567/8
EXP: DD/MM/YYYY
PL 10383/1005
ECMA: 991372
Manufactured by Laboratoire Chauvin S.A, Cedex France
Trademark Holder: Otsuka Pharmaceuticals Co.,Ltd Japan.
Procured from within the EU by the PL Holder: Primecrown Ltd., 28, Sarum
Complex, Uxbridge, Middlesex UB8 2RZ

Date: 29.11.2006

Sign: Joel

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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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