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Tesco Antifungal Cream

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Document: document 0 change

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

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Clotrimazole

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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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

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a “-31 § “ ?

Antifungal

Cream_______

Antifungal

Cream

Clotrimazole

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—

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

_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. ¹PL 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