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BOOTS MOUTH ULCER GEL

Active substance(s): CETYLPYRIDINIUM CHLORIDE / LIDOCAINE / CETYLPYRIDINIUM CHLORIDE / LIDOCAINE / CETYLPYRIDINIUM CHLORIDE / LIDOCAINE

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Internally Approved

Page 1

version 1, 26/01/15

Carton (Label-leaflet) for Sore Mouth Gel

Sore Mouth Gel
Cetylpyridinium Chloride, Lidocaine




Rapidly relieves mouth ulcer pain
Soothing antiseptic
Adults and children

15g e
Read all of this carton for full instructions.

What this medicine is for
An antiseptic gel for the rapid relief of common mouth ulcer pain.

Before you use this medicine
X Do not use:

 If you are allergic to any of the ingredients
You can use this medicine if you are pregnant or breastfeeding.

 How to use this medicine
Check the tube seal is not broken before first use. If it is, do not use the gel.
Pierce tube seal with end of cap.
Adults and children: Apply a small amount of gel to the affected area with a clean finger,
every 3 hours during the day, if you need to. Sore Mouth Gel is not suitable for teething
troubles in babies.
If symptoms do not go away within 7 days talk to your doctor or dentist.
If you use too much: Talk to a pharmacist or doctor.

Possible side effects
Most people will not have problems, but some may get some.
! If you get any of these serious side effects, stop using the gel. See a doctor at once:
 Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

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 carton. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.

How to store this medicine
Do not store above 25°C.
Keep all medicines out of the sight and reach of children.
Use by the date on the end flap of the carton.

Internally Approved

Page 2

version 1, 26/01/15

Carton (Label-leaflet) for Sore Mouth Gel

If you need more advice ask your pharmacist

Active ingredients
This oral gel contains Cetylpyridinium Chloride 0.02% w/w, Lidocaine 0.6% w/w.
Also contains: purified water, ethanol (33.9 vol %), sucrose, hypromellose, cetomacrogol
1000, star anise oil, eucalyptol, levomenthol.
PL 00014/0150
Text prepared 01/15
Manufactured for the Marketing Authorisation Holder The Boots Company PLC Nottingham
NG2 3AA by BCM Ltd, Nottingham NG2 3AA.
15g e
Component code

PACK MOCK UP BOX
Product Name: Sore Mouth Gel
Product Licence No: 00014/0150
Wording Ref: BTC171242 vA 03/12/14
Status: Internally Approved
Pack details: Internally lacquered aluminium tube (polyamide/polyimide lacquer system) with
a membrane seal fitted with a wadless polyethylene cap or a polypropylene cap.
Pack size: 15g
Version No: 1
Date issued: 26/01/2015
Reason for change: ADR reporting statement, and batch release address BCM Ltd NG23AA

Internally Approved

Page 1

version 1, 26/01/15

Label for Sore Mouth Gel

Sore Mouth Gel
Cetylpyridinium Chloride, Lidocaine
 Rapidly relieves mouth ulcer pain
 Soothing antiseptic
 Adults and children
Read all of the carton for full instructions.
 How to use this medicine
Pierce tube seal with end of cap.
Adults and children: Apply a small amount of gel to the affected area with a clean finger,
every 3 hours during the day, if you need to. Sore Mouth Gel is not suitable for teething
troubles in babies.
How to store this medicine
Do not store above 25°C.
Keep all medicines out of the sight and reach of children.
Active ingredients:
This oral gel contains Cetylpyridinium Chloride 0.02% w/w, Lidocaine 0.6% w/w.
Also contains: purified water, ethanol (33.9 vol %), sucrose, hypromellose, cetomacrogol
1000, star anise oil, eucalyptol, levomenthol.
PL 00014/0150
The Boots Company PLC Nottingham NG2 3AA
15g e
Component code
PIP code
USE BY
LOT
PACK MOCK UP BOX
Product Name: Sore Mouth Gel
Product Licence No: 00014/0150
Wording Ref: BTC126493 vD 04/02/14
Status: Internally Approved
Pack details: Internally lacquered aluminium tube (polyamide/polyimide lacquer system)
with a membrane seal fitted with a wadless polyethylene cap or a polypropylene cap.
Pack size: 15g
Version No: 1
Date issued: 26/01/2015
Reason for change: A4 text submitted with ADR reporting statement

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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