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THE 50:50 OINTMENT - patient leaflet, side effects, dosage

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Patient leaflet - THE 50:50 OINTMENT

Before you use

X Do not use:

  • If you are allergic to any of the ingredients.

You can use this medicine if you are pregnant or breastfeeding.

This ointment is greasy, and so if you apply it to your hands, be careful if you drive or use machines.

✓ How to use

  • Adults and children: Apply a thin layer of ointment to the affected area. Apply in the direction of hair growth to help prevent irritation of hair follicles. Apply when you need to, at least twice a day or ideally three or four times a day.

If you are an adult treating a large area of your body you may use up to one tub a week. For use on the skin only. If anyone accidentally swallows some: Talk to a pharmacist or doctor.


Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Possible side effects

Most people will not have problems, but some may get some of these: Rarely, allergic reactions (e.g. skin rash, red or itchy skin) Irritation of hair follicles, if used for a long period of time

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this label. You can also report side effects directly via the Yel low Card Scheme at: or search for MHRA Yellow Card in


the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store

Do not store above 25°C.

Store in the original container.

Stir well if the ointment starts to separate.

Keep all medicines out of the sight and reach of children.

Use by the date on the base or side of tub.

Active ingredients

This ointment for cutaneous use contains Liquid Paraffin 50% w/w, White Soft Paraffin 50% w/w.

PL 00014/06220

Text prepared: 07/19

Manufactured for BCM Specials by BCM Ltd Nottingham NG2 3AA.

The Marketing Authorisation holder is

The Boots Company PLC Nottingham NG2 3AA.

If you need more advice ask your pharmacist.





ARTWORK TEXT SIZE


Main Headings: 7.5 pt

Sub Headings: 7.5 pt

Body Copy: 7.5 pt



ARTWORK ONLY


Trident Reference No: BTC275656

Zen Ref: TR1261173

Category:

HRO

Sub-Category:

Healthcare

Brand:

Boots

Pack Type:

Skin Care

Variant:

The 50:50 Ointment

Action:

F

Date:

08/08/19

Country:

UK

Component Code:

NBJHO

Item Code:

41–88–063

CAD Ref No:

190×70mm

Printer:

N/A

Substrate:

White Raper Label

Barcode Type: EAN 13

Barcode Number: 5000167028362

Magnification: 85%

Barcode Truncated By: 9.5 mm

(smallest bar)

Edgemark Position: N/A

Pharmacode No/NE: N/A


PACK MOCK OP

Product Name: The 50:50 Ointment

Product Licence No.: 00014/0622

Wording Ref: MHRA approved vl dated 20/05/15 (BTC183514 v C)

Status: I nterna 1 ly a p p ro ved

Pack Details: Polypropylene jar with unlined

polyethylene cap.

Pack Size:

500 g.

Version No.

Date Issued

Reason For Change

1

22/05/2017

Paraffin safety update

2

03/05/2019

Further guidance has been received from the MHRA. This is a Mandatory safety update – risk of severe burn injury and death. The yellow card statement has also been updated to include reference to the MHRA Yellow Card App.

3

29/07/2019

RFI received to re-create boxed warning as per MHRA letter.


Cutter | Guides

Colours


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.


230 mm


70 mm



Dan

specials


The


50:50

Before you use

X Do not use:

  • If you are allergic to any of the ingredients.

You can use this medicine if you are pregnant or breastfeeding.

This ointment is greasy, and so if you apply it to your hands, be careful if you drive or use machines.

✓ How to use

  • Adults and children: Apply a thin layer of ointment to the affected area. Apply in the direction of hair growth to help prevent irritation of hair follicles. Apply when you need to, at least twice a day or ideally three or four times a day.

If you are an adult treating a large area of your body you may use up to one tub a week. For use on the skin only. If anyone accidentally swallows some: Talk to a pharmacist or doctor.


Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Possible side effects

Most people will not have problems, but some may get some of these: Rarely, allergic reactions (e.g. skin rash, red or itchy skin) Irritation of hair follicles, if used for a long period of time

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this label. You can also report side effects directly via the Yel low Card Scheme at: or search for MHRA Yellow Card in


the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store

Do not store above 25°C.

Store in the original container.

Stir well if the ointment starts to separate.

Keep all medicines out of the sight and reach of children.

Use by the date on the base or side of tub.

Active ingredients

This ointment for cutaneous use contains Liquid Paraffin 50% w/w, White Soft Paraffin 50% w/w.

PL 00014/06220

Text prepared: 07/19

Manufactured for BCM Specials by BCM Ltd Nottingham NG2 3AA.

The Marketing Authorisation holder is

The Boots Company PLC Nottingham NG2 3AA.

If you need more advice ask your pharmacist.





ARTWORK TEXT SIZE


Main Headings: 7.5 pt

Sub Headings: 7.5 pt

Body Copy: 7.5 pt



ARTWORK ONLY


Trident Reference No: BTC275656

Zen Ref: TR1261173

Category:

HRO

Sub-Category:

Healthcare

Brand:

Boots

Pack Type:

Skin Care

Variant:

The 50:50 Ointment

Action:

F

Date:

08/08/19

Country:

UK

Component Code:

NBJHO

Item Code:

41–88–063

CAD Ref No:

190×70mm

Printer:

N/A

Substrate:

White Raper Label

Barcode Type: EAN 13

Barcode Number: 5000167028362

Magnification: 85%

Barcode Truncated By: 9.5 mm

(smallest bar)

Edgemark Position: N/A

Pharmacode No/NE: N/A


PACK MOCK OP

Product Name: The 50:50 Ointment

Product Licence No.: 00014/0622

Wording Ref: MHRA approved vl dated 20/05/15 (BTC183514 v C)

Status: I nterna 1 ly a p p ro ved

Pack Details: Polypropylene jar with unlined

polyethylene cap.

Pack Size:

500 g.

Version No.

Date Issued

Reason For Change

1

22/05/2017

Paraffin safety update

2

03/05/2019

Further guidance has been received from the MHRA. This is a Mandatory safety update – risk of severe burn injury and death. The yellow card statement has also been updated to include reference to the MHRA Yellow Card App.

3

29/07/2019

RFI received to re-create boxed warning as per MHRA letter.


Cutter | Guides

Colours


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.


230 mm


70 mm



Dan

specials


The


50:50

Ointment


Liquid Paraffin, White Soft Paraffin)


emollient for the symptomatic relief of dry skin conditions


New safety Information – see label


500 g e


Read all of this label for full instructions.

Before you use

X Do not use:

  • If you are allergic to any of the ingredients.

You can use this medicine if you are pregnant or breastfeeding.

This ointment is greasy, and so if you apply it to your hands, be careful if you drive or use machines.

✓ How to use

Adults and children: Apply a thin layer of ointment to the affected area. Apply in the direction of hair growth to help prevent irritation of hair follicles. Apply when you need to, at least twice a day or ideally three or four times a day.

If you are an adult treating a large area of your body you may use up to one tub a week. For use on the skin only. If anyone accidentally swallows some: Talk to a pharmacist or doctor.


Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact v*th tl> product burns more easiysn4i*a se»ous fire hazard. Washin*clothing and bedding*


  • the Google Play or Apple App Store. By reporting side effects you can help provide more information on ih^afety this medicine. s 9 £ow|p^qfe

£o not store above 25°C. * * Store in the original container.


may reduce product build-up but not

  • totally remove i* Ctiawell *tbe ointment starts to separate.

Possible side efltcf#


  • Most people wit not have i^obl^hs, but some may get some of these: Rarely, allergic reactions (e.g. skin rash, red or itchy skin)

Irritation of hair follicles, if used for a long period of time

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this label. You can also report side effects directly via the Yel low Card Scheme at: or search for MHRA Yellow Card in


Keep all medieiNss out of the sight and reach ofthildfen.

Use by the date on the base or side of tub.

Active ingredients

This ointment for cutaneous use contains Liquid Paraffin 50% w/w, White Soft Paraffin 50% w/w.

PL 00014/06220

Text prepared: 07/19

Manufactured for BCM Specials by BCM Ltd Nottingham NG2 3AA.

The Marketing Authorisation holder is

The Boots Company PLC Nottingham NG2 3AA.

If you need more advice ask your pharmacist.




E5636

41–88–063


ARTWORK TEXT SIZE


Main Headings:

7.5 pt

Sub Headings:

7.5 pt

Body Copy:

7.5 pt


BRAILLE CONVERSION – English



TU ~ Number r- rx. Number r-

I he Sign 50 : Sign 50

Ointment


PACK MOCK OP

ProductName: The 50:50 Ointment

Product Licence No.: 00014/0622

Wording Ref: MHRA approved vl dated 2B/05/15 (BTC183514 v C)

Status: I nterna 1 ly a p p ro ved

Pack Details: Polypropylene jar with unlined

polyethylene cap.

Pack Size:

500 g.

Version No.

Date Issued

Reason For Change

1

22/05/2017

Paraffin safety update

2

03/05/2019

Further guidance has been received from the MHRA. This is a Mandatory safety update – risk of severe burn injury and death. The yellow card statement has also been updated to include reference to the MHRA Yellow Card App.

3

29/07/2019

RFI received to re-create boxed warning as per MHRA letter.


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.


ARTWORK ONLY


Trident Reference No: BTC275656


Zen Ref: Category: Sub-Category: Brand: Pack Type: Variant:


Action:

Date: Country:


TR1261173

HRO

Healthcare

Boots

Skin Care

The 50:50 Ointment


F

08/08/19

UK


Com ponent Code: N BJ H 0

Item Code: 41 –88–063


CAD Ref No: Printer: Substrate:


190×70mm

N/A

White Raper Label


Barcode Type:

Barcode Number:

Magnification:

Barcode Truncated By: (smallest bar)

Edgemark Pbsition:

Pharmacode No/NE:


EAN 13 5000167028362

85%

9.5 mm


N/A

N/A


PANTONE 280C


Colours

Cutter | Guides


230 mm


ARTWORK ONLY


70 mm


Trident Reference No: BTC275656

Zen Ref:

Category: HRO

Sub-Category: Healthcare

Brand: Boots

Pack Type: Skin Care

Variant:

Action: Date: Country: UK

Component Code:

Item Code:

CAD Ref No: 190×70mm

Printer:

Substrate:


ARTWORK TEXT SIZE


Main Headings:

7.5 pt

Sub Headings:

7.5 pt

Body Copy:

7.5 pt


BRAILLE CONVERSION – English



PACK MOCK OP

Prod u ct Na m e: The 50:50 Ointment

Product Licence No.: 00014/0622

Wording Ref: MHRA approved vl dated 2B/05/15 (BTC183514 v C)

Status: I nterna 1 ly a p p ro ved

Pack Details: Polypropylene jar with unlined

polyethylene cap.

Pack Size:

500 g.

Version No.

Date Issued

Reason For Change

1

22/05/2017

Paraffin safety update

2

03/05/2019

Further guidance has been received from the MHRA. This is a Mandatory safety update – risk of severe burn injury and death. The yellow card statement has also been updated to include reference to the MHRA Yellow Card App.

3

29/07/2019

RFI received to re-create boxed warning as per MHRA letter.


Barcode Type:

Barcode Number:

Magnification:

Barcode Truncated By: (smallest bar)

Edgemark Position:

Pharmacode No/NE:

| | Cutter | Guides



TL ~ Number r- rx. Number r-

I he Sign 50 : Sign 50

Ointment


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.


230 mm


70 mm


ARTWORK TEXT SIZE


Main Headings:

7.5 pt

Sub Headings:

7.5 pt

Body Copy:

7.5 pt



ARTWORK

ONLY

Trident Reference No: BTC275656

Zen Ref: TR1261173

HRO

Healthcare

Boots

Skin Care

The 50:50 Ointment

F

08/08/19

UK

Component Code: NBJH0

Item Code: 41

-88–063

CAD Ref No: 190×70mm

Printer: N/A

Substrate: White Paper Label

BarcodeType: EAN 13

Barcode Number: 50001 67028362

Magnification: 85%

BarcodeTruncated By: 9.5 mm

(smallest bar)

Edgemark Position: N/A

Pharmacode No/NE: N/A

Colours

Process Cyan ProcessYellow Process Black PANTONE 280 C

1

2 3 4

— — —

PANTONE144C Braille

Pattern Gloss Varnish

5

6 7

— —