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 |
| — | — — |