Medine.co.uk

Clotrimazole 1% W/W Cream

Informations for option: Clotrimazole 1% W/W Cream, show other option
Document: label-leaflet BOOTS_PL 00289-1490 change

133-25 i

133-25 i

REG0064468    Version 1.2    Approved    Page 1 of 5





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REG0064468    Version 1.2    Approved    Page 2 of 5




1$ aa o n n r

3 a g g 3.°-

" zj Gf|» o " -

3" Q. n ~0 su IQ r < w OTJ tf.fi , o o 3. sr ° S r

= 2 “ S.= 3 £

_ -h ' “or 3. § g- J Q.-D «

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5+ =■ ST o "5 c 3' p n S-o : 5 =3-8 e

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Clotrimazole

l_

V Treats a wide range of fungal


Antifungal

Cream.


Antifungal

Cream








• • •    • •• • •• •• • •

• •• • • • •• • • • ••• •








ARTWORK ONLY




TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No: BTC1 85570

Zen Ref:

TR957968

Category:

Healthcare

Sub-Category:

Skin Care

Brand:

Good

Pack Type:

carton

Variant:

Antifungal Cream

Action:

B

Date:

06/05/15

Country:

UK

Component Code:

63681-C

Item Code:

61-04-924

CAD ReT No:

32x32x124mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

5000167082425

Magnification:

85%

Barcode Truncated By: 11.5 mm

(smallest bar)

Edgemaik Position:

N/A

Pharmacnde No/NE:

N/A

Technical a Non Printing Items Cutter ■ Guides


ARTWORK TEXT SIZE

Main Headings: 8pt Sub Headings: 7pt Body Copy: 6.5pt

PACK MOCK UP

Product Name: Antifungal Cream Product Licence No.: 00289/1490

Wording Ref: MHRA Approved VI dated 22^)1/2013 (B1C102400v B) Status: internally Approved Park Details: Aluminium tube with polypropylene screw on cap containing 20 g of cream.

Pack Size: 20 g

BRAILLE CONVERSION - English Alphabet

• •• • • ••••••••••••••

• • •• • • •• • • • •• • • ••• •• ••• •

• • • • • ••

• • •

Version No.

Date Issued

Reason For Change

1

22/01/2013

M H RA Acceptance of excipient change to EP reference standard.

Boots Antifungal Cream

2

20/04/2015

Add Section 4.8 ADR Reporting Update


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hrttsm Qbs Virrtdi

Bnlk


TRIDENT


Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 028100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION PROM TRIDENT.


STUDIO USE ONLY Evita Lauka    »i.

Sm»Art check results: G=1;0=2;R=0; - EL-06/05/1516:19:00


REG0064468    Version 1.2    Approved    Page 4 of 5



1$ o n n ^ r

3 a § g 3.°-

" zj Gf|» o " -

3" Q_ n ~0 su IQ r < w OTJ tf.o , o o 3. sr ° S r

= 2 “ S.3 3 c

_ -h 2- ' “nr

“ g- 2 Q.-D «

3-^o.S S = E

5+ =■ or o "5 c — 3' p n 3-0 =

5 =3-8 e

as -h « T eu 12 S

a “-31 § “ ?






Antifungal

Cream_______



Antifungal

Cream

Clotrimazole

l_

V Treats a wide range of fungal Infections of the skin






Teva Pharmaceuticals Europe B.V

1.3.2 mockup-outer-uk-pl-00289-1490-clotrimazole-l-percent-cream-boots

Approvals

Signed by


Annette Huggett


REG0064468


Meaning of Signature


Regulatory Affairs Approval


Version 1.2


Approved


Server Date


21-May-2015 04:31:53 PM


Page 5 of 5


—i—

I


ARTWORK ONLY


REG0064470    Version 2.0    Effective    1    Page 1 of 2



Antifungal

Cream :

Clotrimazole


V Treats a wldb range of fungal Infeictlons of the skin


B


l


L__20_ue


"Read al ofthe parfon forTull instructions. ,

Uses: An antifurpil cream for the treatment of fungal skin infections including ringwofm, fungal nappy rash, infections qf the armpit, groin, toes and skin folds and thrush of the vulva a penis, i /Howto use this medicine Check the tube seai is not broken before first use. If it is, do not use the cream.    i

Pierce tube seai with end of cap. Adults and children: Apply to the affected area twd or three tines a day. Use the cream fer at least 2 weeks. Apply to the skin1 only.

Do not use mord than the amount recommended abwe.

If symptoms do {rot improve within 7 days, or do no| go away, talk to your doctor.

Keep al medicjnes out of the sight and reach of children.

Use by the date pn the tube edge. Active ingredent

This topical cream contains Clotrimazole 1%iw/w.

Also contains: purified water, 2-octytdodecanol, stearyi alcohol, cetyl alcohol, cetyl palmitate, sorbitan stearate, poiysorbate 60, benzyl alcohol. PL 00289/1490'    [0

The Boots Comfbany PLC Nottingham NG2 3AA.

MA hdd by TEVA UK Umited .BiSlta™BN2}L9«l _ B3682-S


Trident Reference No: BTCl 02401

Zen Ref:

TR564381

Category:

Healthcare

Sub-Category:

Skin Care

Brand:

Good

Pack Type:

Tube

Variant:

Antifungal Cream

Action:

A

Date:

30/03/12

Country:

UK

Component Code:

63682-B

Item Code:

61-04-924

CAD Ref No:

116x67.5mm

Printer:

N/A

Substrate:

White Aluminum

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: N/A

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical ft Non Printing Items Cutter ■ Guides


ARTWORK TEXT SIZE


Main Headings:

N/A

Sub Headings:

N/A

Body Copy:

Gpt


PACK 1VIOCK IIP


Product Name:


Antifungal Cream


Product Licence No.: 00289/1490

Wording Ref:    MHRAapproved v1 dated 6/6/11 (BTC80135 vC)

Status:    l nterna l ly a pp roved

Pack Details:    Aluminium tube with polypropylene

screw on cap containing 20 g of cream.


Connaught House, Connaught Road, Kingswood Business PaTk, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


TRIDENT


TECHNICAL INFO: PRINTER PLEASE NOTE Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Pack Size:


20 g


Reason For Change


28/3/12


Excipient change to EP reference standard


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Philip Ives    vl.0

Sm«Art check results: 6=0; 0=0; R=0; - Pi - 30/03/1211:14:48


Teva Pharmaceuticals Europe B.V 1.3.2

mockup-inner(tube)-uk-pl-00289-1490-clotrimazole-l-percent-cream-boots

Approvals

Signed by


Annette Huggett


REG0064470


Meaning of Signature


Regulatory Affairs Approval


Version 2.0


Effective


Server Date


21-May-2015 04:29:47 PM


Page 2 of 2