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CUSTOMER INFO: Minimum Point Size = 4.6 mm 90% EAN 13 5000167002010 16.0 mm 0 microns N/A 18.9 mm BARCODE INFO Barcode Type: Barcode Number: Magnification: Truncated By: Full Height: Bar Height (Smallest Bar): BWR: Encoded Data: Trident Reference No: ZEN Ref: Action: Brand: Category: Segment Group: Segment: Pack Size: Market/Country: Date: Component Code (2D if applicable): Parent Technical Packaging Specification: Finished Goods Code: Supply Point: Pharmacode No/NE: Edgemark Position: CAD Cam Ref: Printer: Substrate: 000100(67) RB Hull N/A 2753960 Hc45 Treatment Anti-Inflammatory 15g 15g RB344330 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. STUDIO USE ONLY v2.0 Sm•Art check results: Cutter Guides Technical & Non Printing Items Cutter 2 (if applicable) Guides 2 (if applicable) Medica Packaging Limited (Crewe, UK) E45-Crt-D0121087-Hull-107x32x32mm TR1454061 Carton Board - White UK and Ireland 17/01/19 D Mel Hall 3082233 G=2; O=0; R=0; - MH - 17/01/19 14:29:42 RB Artwork and Print Specification D0121087 Artwork Type: IDM Commercial 10 mm 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 1 LTH Process Yellow 2 LTH Process Magenta 3 LTH PANTONE 2995 C 4 LTH PANTONE 1555 C 5 LTH PANTONE 661 C 6 LTH PANTONE Cool Gray 10 C 7 LTH Varnish - High Gloss UV 8 LTH Braille Colours (Carton) RBH Contact: Jillian Buckle Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT. 6.00pt Hc 9 45 Hydrocortisone Cream TBR1965-D0121087 – English 15g hydrocortisone acetate cream hydrocortisone acetate cream 4.POSSIBLE SIDE EFFECTS: Maycause local skin reactions. If anything unusual happens, stop usingthe product. Ifyou get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible sideeffects not listed above. You can also report side effects directly via theYellow Card Scheme at: http://www.mhra.gov.uk/yellowcard (UK)orvia http://www.hpra.ie (Ireland). By reporting side effects, you can help provide more information on the safety of this medicine. 5.HOW TO STORE THIS MEDICINE: Store below 25°C. KEEP OUT OFTHE SIGHT AND REACH OF CHILDREN 6.FURTHERINFORMATION:Hc45 is a whitecreamcontaining HydrocortisoneAcetate 1% w/w asthe activeingredient andwhite soft paraffin, liquidparaffin,phenoxyethanol,purifiedwater,cetomacrogol emulsifyingwaxwithcetostearyl alcohol. PL holder: Reckitt Benckiser Healthcare (UK) Ltd,SL1 4AQ. PL 00063/0647 PAholder:ReckittBenckiserIrelandLtd.,CitywestBusinessCampus,Dublin24. PA979/45/1 Manufacturers: RB Healthcare (UK) Ltd, HU8 7DS,UK and RB NL Brands B.V. Schiphol Blvd 207, 1118 BHSchiphol, NL. Textrevised:December2018. hydrocortisone acetate cream Hydrocortisone Acetate 1% w/w Treatment for Eczema, Dermatitis & Insect Bites 1.WHAT Hc45 ISUSED FOR: Hc45 works by alteringthe body’s responses to inflammatory reactions due to irritant contact dermatitis, allergic contact dermatitis, insect bites and mild to moderate eczema. 2.BEFORE YOU USE Hc45: Use this medicine only on your skin to cover the affected area. Do not cover with a dressing. Do not use if allergic to any of the ingredients.ContainsCetostearyl Alcohol which maycause local skin reactions (e.g.contact dermatitis). Do not use on the eyes, face, anal or genital areas, on broken skin or infected skin, e.g impetigo, cold sores, acne, athletes foot or infected bites and stings. Do not use in pregnancy, breast-feeding or on children under 10 without medical advice. Check that the tube seal is intact before first use, then remove it. 3.HOW TO USE Hc45: Use sparingly on small skin areas, once or twice a day for a maximum of 7 days. If the condition does not improve, consult your doctor. 3082233 LOT USE BY E E R F H S I N R A V & K N I E E R F H S I N R A V & K N I Reckitt Benckiser 0000 PA 979/45/1 Addition of BR and BT Sites 1.3.1 Outer Packaging HC45 Cream eCTD Page 1
5

Reckitt Benckiser - HPRA€¦ · PL holder: Reckitt Benckiser Healthcare (UK) Ltd,SL1 4AQ. PL 00063/0647 PAholder:ReckittBenckiserIrelandLtd.,CitywestBusinessCampus,Dublin24. PA 979/45/1

May 20, 2020

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Page 1: Reckitt Benckiser - HPRA€¦ · PL holder: Reckitt Benckiser Healthcare (UK) Ltd,SL1 4AQ. PL 00063/0647 PAholder:ReckittBenckiserIrelandLtd.,CitywestBusinessCampus,Dublin24. PA 979/45/1

CUSTOMER INFO:Minimum Point Size = 6.00pt

4.6 mm

90%

EAN 13

5000167002010

16.0 mm

0 microns

N/A

18.9 mm

BARCODE INFOBarcode Type:

Barcode Number:

Magnification:

Truncated By:

Full Height:

Bar Height (Smallest Bar):

BWR:

Encoded Data:

Trident Reference No:

ZEN Ref:

Action:

Brand:

Category:

Segment Group:

Segment:

Pack Size:

Market/Country:

Date:

Component Code (2D if applicable):

Parent Technical Packaging

Specification:

Finished Goods Code:

Supply Point:

Pharmacode No/NE:

Edgemark Position:

CAD Cam Ref:

Printer:

Substrate:

000100(67)

RB Hull

N/A

2753960

Hc45

Treatment

Anti-Inflammatory

15g

15g

RB344330

Please note that any low resolution paper Canon colour copiesassociated with this job should be referred to for content, layout

and colour separation only.

STUDIO USE ONLY v2.0

Sm•Art check results:

Cutter

Guides

Technical & Non Printing Items

Cutter 2 (if applicable)

Guides 2 (if applicable)

Medica Packaging Limited (Crewe, UK)

E45-Crt-D0121087-Hull-107x32x32mm

TR1454061

Carton Board - White

UK and Ireland

17/01/19

D

Mel Hall

3082233

G=2; O=0; R=0; - MH - 17/01/19 14:29:42

RB Artwork andPrint Specification

D0121087

Artwork Type: IDM Commercial

10m

m20

3040

5060

7080

9010

011

012

013

014

015

016

017

018

019

020

021

022

023

024

025

0

1LTH

Process Yellow2

LTH

Process Magenta3

LTH

PANTONE 2995 C4

LTH

PANTONE 1555 C

5LTH

PANTONE 661 C6

LTH

PANTONE Cool Gray 10 C

7LTH

Varnish - High Gloss UV8

LTH

Braille

Colours (Carton)

RBH Contact: Jillian Buckle

Connaught House, Connaught Road,Kingswood Business Park, Hull, HU7 3AP, England.

T: +44 (0) 1482 828100

UNDER NO CIRCUMSTANCES SHOULD THISARTWORK BE ALTERED WITHOUT PRIOR

PERMISSION FROM TRIDENT.

6.00pt

Hc945H ydrocor t isoneCream

T B R 1 9 6 5 - D 0 1 2 1 0 8 7 – E n g l i s h

15g

hydr

ocor

tiso

neac

etat

ecr

eam

hydrocortisoneacetate

cream

4.POSSIBLE SIDE EFFECTS: May cause local skin reactions. Ifanything unusual happens, stop using the product. If you getany side effects, talk to your doctor, pharmacist or nurse. Thisincludes any possible side effects not listed above.You can also report side effects directly via the Yellow CardScheme at: http://www.mhra.gov.uk/yellowcard (UK) or viahttp://www.hpra.ie (Ireland). By reporting side effects, you canhelp provide more information on the safety of this medicine.5.HOW TO STORE THIS MEDICINE: Store below 25°C.KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

6.FURTHER INFORMATION: Hc45 is a white cream containingHydrocortisoneAcetate 1% w/w as the active ingredient and white softparaffin, liquid paraffin, phenoxyethanol, purified water, cetomacrogolemulsifying wax with cetostearyl alcohol.PL holder: Reckitt Benckiser Healthcare (UK) Ltd, SL1 4AQ.PL 00063/0647PA holder: Reckitt Benckiser Ireland Ltd.,Citywest BusinessCampus, Dublin 24. PA 979/45/1Manufacturers: RB Healthcare (UK) Ltd, HU8 7DS, UK and RB NL Brands B.V.Schiphol Blvd 207, 1118 BH Schiphol, NL.Text revised: December 2018.

hydrocortisoneacetate creamHydrocortisone Acetate 1% w/w

Treatment for Eczema, Dermatitis & Insect Bites

1.WHAT Hc45 IS USED FOR: Hc45 works by altering the body’sresponses to inflammatory reactions due to irritant contactdermatitis, allergic contact dermatitis, insect bites and mild tomoderate eczema.2.BEFORE YOU USE Hc45: Use this medicine only on your skinto cover the affected area. Do not cover with a dressing. Do notuse if allergic to any of the ingredients. Contains CetostearylAlcohol which may cause local skin reactions (e.g. contactdermatitis).

Do not use on the eyes, face, anal or genital areas, on broken skinor infected skin, e.g impetigo, cold sores, acne, athletes foot orinfected bites and stings. Do not use in pregnancy,breast-feeding or on children under 10 withoutmedical advice.Check that the tube seal is intact before first use, then remove it.3.HOW TO USE Hc45: Use sparingly on small skin areas, onceor twice a day for a maximum of 7 days.If the condition does not improve, consult your doctor.

3082233

LOT

USE

BY

EERF HSI NRAV & KNIEERF HSI NRAV & KNI

Reckitt Benckiser 0000 PA 979/45/1 Addition of BR and BT Sites

1.3.1 Outer PackagingHC45 Cream eCTD Page 1

Page 2: Reckitt Benckiser - HPRA€¦ · PL holder: Reckitt Benckiser Healthcare (UK) Ltd,SL1 4AQ. PL 00063/0647 PAholder:ReckittBenckiserIrelandLtd.,CitywestBusinessCampus,Dublin24. PA 979/45/1

CUSTOMER INFO:Minimum Point Size = 6.00pt

4.6 mm

90%

EAN 13

5000167002010

16.0 mm

0 microns

N/A

18.9 mm

BARCODE INFOBarcode Type:

Barcode Number:

Magnification:

Truncated By:

Full Height:

Bar Height (Smallest Bar):

BWR:

Encoded Data:

Trident Reference No:

ZEN Ref:

Action:

Brand:

Category:

Segment Group:

Segment:

Pack Size:

Market/Country:

Date:

Component Code (2D if applicable):

Parent Technical Packaging

Specification:

Finished Goods Code:

Supply Point:

Pharmacode No/NE:

Edgemark Position:

CAD Cam Ref:

Printer:

Substrate:

000100(67)

RB Hull

N/A

2753960

Hc45

Treatment

Anti-Inflammatory

15g

15g

RB344330

Please note that any low resolution paper Canon colour copiesassociated with this job should be referred to for content, layout

and colour separation only.

STUDIO USE ONLY v2.0

Sm•Art check results:

Cutter

Guides

Technical & Non Printing Items

Cutter 2 (if applicable)

Guides 2 (if applicable)

Medica Packaging Limited (Crewe, UK)

E45-Crt-D0121087-Hull-107x32x32mm

TR1454061

Carton Board - White

UK and Ireland

17/01/19

D

Mel Hall

3082233

G=2; O=0; R=0; - MH - 17/01/19 14:29:42

RB Artwork andPrint Specification

D0121087

Artwork Type: IDM Commercial

10m

m20

3040

5060

7080

9010

011

012

013

014

015

016

017

018

019

020

021

022

023

024

025

0

1LTH

Process Yellow2

LTH

Process Magenta3

LTH

PANTONE 2995 C4

LTH

PANTONE 1555 C

5LTH

PANTONE 661 C6

LTH

PANTONE Cool Gray 10 C

7LTH

Varnish - High Gloss UV8

LTH

Braille

Colours (Carton)

RBH Contact: Jillian Buckle

Connaught House, Connaught Road,Kingswood Business Park, Hull, HU7 3AP, England.

T: +44 (0) 1482 828100

UNDER NO CIRCUMSTANCES SHOULD THISARTWORK BE ALTERED WITHOUT PRIOR

PERMISSION FROM TRIDENT.

6.00pt

Hc945H ydrocor t isoneCream

T B R 1 9 6 5 - D 0 1 2 1 0 8 7 – E n g l i s h

15g

hydr

ocor

tiso

neac

etat

ecr

eam

hydrocortisoneacetate

cream

4.POSSIBLE SIDE EFFECTS: May cause local skin reactions. Ifanything unusual happens, stop using the product. If you getany side effects, talk to your doctor, pharmacist or nurse. Thisincludes any possible side effects not listed above.You can also report side effects directly via the Yellow CardScheme at: http://www.mhra.gov.uk/yellowcard (UK) or viahttp://www.hpra.ie (Ireland). By reporting side effects, you canhelp provide more information on the safety of this medicine.5.HOW TO STORE THIS MEDICINE: Store below 25°C.KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

6.FURTHER INFORMATION: Hc45 is a white cream containingHydrocortisoneAcetate 1% w/w as the active ingredient and white softparaffin, liquid paraffin, phenoxyethanol, purified water, cetomacrogolemulsifying wax with cetostearyl alcohol.PL holder: Reckitt Benckiser Healthcare (UK) Ltd, SL1 4AQ.PL 00063/0647PA holder: Reckitt Benckiser Ireland Ltd.,Citywest BusinessCampus, Dublin 24. PA 979/45/1Manufacturers: RB Healthcare (UK) Ltd, HU8 7DS, UK and RB NL Brands B.V.Schiphol Blvd 207, 1118 BH Schiphol, NL.Text revised: December 2018.

hydrocortisoneacetate creamHydrocortisone Acetate 1% w/w

Treatment for Eczema, Dermatitis & Insect Bites

1.WHAT Hc45 IS USED FOR: Hc45 works by altering the body’sresponses to inflammatory reactions due to irritant contactdermatitis, allergic contact dermatitis, insect bites and mild tomoderate eczema.2.BEFORE YOU USE Hc45: Use this medicine only on your skinto cover the affected area. Do not cover with a dressing. Do notuse if allergic to any of the ingredients. Contains CetostearylAlcohol which may cause local skin reactions (e.g. contactdermatitis).

Do not use on the eyes, face, anal or genital areas, on broken skinor infected skin, e.g impetigo, cold sores, acne, athletes foot orinfected bites and stings. Do not use in pregnancy,breast-feeding or on children under 10 withoutmedical advice.Check that the tube seal is intact before first use, then remove it.3.HOW TO USE Hc45: Use sparingly on small skin areas, onceor twice a day for a maximum of 7 days.If the condition does not improve, consult your doctor.

3082233

LOT

USE

BY

EERF HSI NRAV & KNIEERF HSI NRAV & KNI

Reckitt Benckiser 0000 PA 979/45/1 Addition of BR and BT Sites

1.3.1 Outer PackagingHC45 Cream eCTD Page 2

Page 3: Reckitt Benckiser - HPRA€¦ · PL holder: Reckitt Benckiser Healthcare (UK) Ltd,SL1 4AQ. PL 00063/0647 PAholder:ReckittBenckiserIrelandLtd.,CitywestBusinessCampus,Dublin24. PA 979/45/1

CUSTOMER INFO:Minimum Point Size = 6.00pt

4.6 mm

90%

EAN 13

5000167002010

16.0 mm

0 microns

N/A

18.9 mm

BARCODE INFOBarcode Type:

Barcode Number:

Magnification:

Truncated By:

Full Height:

Bar Height (Smallest Bar):

BWR:

Encoded Data:

Trident Reference No:

ZEN Ref:

Action:

Brand:

Category:

Segment Group:

Segment:

Pack Size:

Market/Country:

Date:

Component Code (2D if applicable):

Parent Technical Packaging

Specification:

Finished Goods Code:

Supply Point:

Pharmacode No/NE:

Edgemark Position:

CAD Cam Ref:

Printer:

Substrate:

000100(67)

RB Hull

N/A

2753960

Hc45

Treatment

Anti-Inflammatory

15g

15g

RB344330

Please note that any low resolution paper Canon colour copiesassociated with this job should be referred to for content, layout

and colour separation only.

STUDIO USE ONLY v2.0

Sm•Art check results:

Cutter

Guides

Technical & Non Printing Items

Cutter 2 (if applicable)

Guides 2 (if applicable)

Medica Packaging Limited (Crewe, UK)

E45-Crt-D0121087-Hull-107x32x32mm

TR1454061

Carton Board - White

UK and Ireland

17/01/19

D

Mel Hall

3082233

G=2; O=0; R=0; - MH - 17/01/19 14:29:42

RB Artwork andPrint Specification

D0121087

Artwork Type: IDM Commercial

10m

m20

3040

5060

7080

9010

011

012

013

014

015

016

017

018

019

020

021

022

023

024

025

0

1LTH

Process Yellow2

LTH

Process Magenta3

LTH

PANTONE 2995 C4

LTH

PANTONE 1555 C

5LTH

PANTONE 661 C6

LTH

PANTONE Cool Gray 10 C

7LTH

Varnish - High Gloss UV8

LTH

Braille

Colours (Carton)

RBH Contact: Jillian Buckle

Connaught House, Connaught Road,Kingswood Business Park, Hull, HU7 3AP, England.

T: +44 (0) 1482 828100

UNDER NO CIRCUMSTANCES SHOULD THISARTWORK BE ALTERED WITHOUT PRIOR

PERMISSION FROM TRIDENT.

6.00pt

Hc945H ydrocor t isoneCream

T B R 1 9 6 5 - D 0 1 2 1 0 8 7 – E n g l i s h

Reckitt Benckiser 0000 PA 979/45/1 Addition of BR and BT Sites

1.3.1 Outer PackagingHC45 Cream eCTD Page 3

Page 4: Reckitt Benckiser - HPRA€¦ · PL holder: Reckitt Benckiser Healthcare (UK) Ltd,SL1 4AQ. PL 00063/0647 PAholder:ReckittBenckiserIrelandLtd.,CitywestBusinessCampus,Dublin24. PA 979/45/1

CUSTOMER INFO:Minimum Point Size = 6.00pt

4.6 mm

90%

EAN 13

5000167002010

16.0 mm

0 microns

N/A

18.9 mm

BARCODE INFOBarcode Type:

Barcode Number:

Magnification:

Truncated By:

Full Height:

Bar Height (Smallest Bar):

BWR:

Encoded Data:

Trident Reference No:

ZEN Ref:

Action:

Brand:

Category:

Segment Group:

Segment:

Pack Size:

Market/Country:

Date:

Component Code (2D if applicable):

Parent Technical Packaging

Specification:

Finished Goods Code:

Supply Point:

Pharmacode No/NE:

Edgemark Position:

CAD Cam Ref:

Printer:

Substrate:

000100(67)

RB Hull

N/A

2753960

Hc45

Treatment

Anti-Inflammatory

15g

15g

RB344330

Please note that any low resolution paper Canon colour copiesassociated with this job should be referred to for content, layout

and colour separation only.

STUDIO USE ONLY v2.0

Sm•Art check results:

Cutter

Guides

Technical & Non Printing Items

Cutter 2 (if applicable)

Guides 2 (if applicable)

Medica Packaging Limited (Crewe, UK)

E45-Crt-D0121087-Hull-107x32x32mm

TR1454061

Carton Board - White

UK and Ireland

17/01/19

D

Mel Hall

3082233

G=2; O=0; R=0; - MH - 17/01/19 14:29:42

RB Artwork andPrint Specification

D0121087

Artwork Type: IDM Commercial

10m

m20

3040

5060

7080

9010

011

012

013

014

015

016

017

018

019

020

021

022

023

024

025

0

1LTH

Process Yellow2

LTH

Process Magenta3

LTH

PANTONE 2995 C4

LTH

PANTONE 1555 C

5LTH

PANTONE 661 C6

LTH

PANTONE Cool Gray 10 C

7LTH

Varnish - High Gloss UV8

LTH

Braille

Colours (Carton)

RBH Contact: Jillian Buckle

Connaught House, Connaught Road,Kingswood Business Park, Hull, HU7 3AP, England.

T: +44 (0) 1482 828100

UNDER NO CIRCUMSTANCES SHOULD THISARTWORK BE ALTERED WITHOUT PRIOR

PERMISSION FROM TRIDENT.

6.00pt

Hc945H ydrocor t isoneCream

T B R 1 9 6 5 - D 0 1 2 1 0 8 7 – E n g l i s h

Reckitt Benckiser 0000 PA 979/45/1 Addition of BR and BT Sites

1.3.1 Outer PackagingHC45 Cream eCTD Page 4

Page 5: Reckitt Benckiser - HPRA€¦ · PL holder: Reckitt Benckiser Healthcare (UK) Ltd,SL1 4AQ. PL 00063/0647 PAholder:ReckittBenckiserIrelandLtd.,CitywestBusinessCampus,Dublin24. PA 979/45/1

Reckitt Benckiser 0000 PA 979/45/1 Addition of BR and BT Sites

1.3.1 Outer PackagingHC45 Cream eCTD Page 5