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1.3.1 Label-Leaflet

PL 00079/0677

November 2013

GlaxoSmithKline Consumer Healthcare

The label-leaflet for the product will be split into 3 sections as indicated by the diagram

Left Section

Middle Section

Right Section

The middle section is the front facing section and will be the branded part of the product.
Braille will also be printed on this section.
The left and right sections will contain all the relevant patient information for the product
such as directions for use, possible side effects, storage and handling etc. Exact details are
provided below.

Text to appear in the Middle Section
Corsodyl Mint Flavour 0.2% w/v Mouthwash
chlorhexidine digluconate
• Bleeding Gums
• Irritated Gums
• Mouth Ulcers
300 ml
< Text in Braille – Corsodyl Mint Flavour 0.2% w/v Mouthwash>

Text to appear in the Right Section
What is Corsodyl Mint Flavour 0.2% w/v Mouthwash for?
The active ingredient is chlorhexidine digluconate which is an antibacterial agent that reduces
the formation of dental plaque and is used to:
• Treat & prevent gum disease (where gums may bleed when brushed)
• Promote gum healing after dental surgery or treatment
• Control mouth ulcers
• Maintain mouth hygiene
• Manage oral thrush and denture sore mouth
Check before you use
Do not use:
• If you have ever had an allergic reaction to chlorhexidine digluconate or any of the
other ingredients (see Storage and further information).

1.3.1 Label-Leaflet
November 2013

PL 00079/0677
GlaxoSmithKline Consumer Healthcare

In children under 12 years unless recommended by a dentist.
Anywhere other than your mouth. Wash thoroughly if you get any in your eyes or ears.
Immediately after brushing your teeth. See How to use for more information.

Take special care with Corsodyl Mint Flavour 0.2% w/v Mouthwash
• Do not bleach fabrics that have been in contact with the mouthwash.
Pregnancy and breast feeding
• You can use the mouthwash if you are pregnant or breast feeding.
How to use
Use only if seal on cap is present and intact before opening.
• Do not swallow
• Do not exceed stated dose.
• Toothpastes can stop the mouthwash working. Rinse your mouth thoroughly with
water and wait 5 minutes after brushing your teeth before using the mouthwash. You can
also use the mouthwash at a different time of day.
• Use twice a day. Fill the cap to 10 ml line. Rinse mouth thoroughly for 1 minute then spit
• Gum disease: A one month course (600 ml) is recommended.
• Mouth ulcers & oral thrush: Continue to use for 2 days after healing has occurred.
• Denture sore mouth: Clean & soak your dentures in the mouthwash for 15 minutes
twice a day.
• Dental surgery: Rinse as directed by your dentist.
If your symptoms persist, see your dentist.

Text to appear in the Left Section
Possible side effects
This mouthwash can have side effects, but not everybody gets them.
• Stop using the mouthwash and seek immediate medical help if you get a rash, swelling
of the mouth or face or have difficulty breathing. These effects may be symptoms of a
severe allergic reaction which is very rare.
• Stop using the mouthwash and tell your dentist if you get irritation of the mouth,
soreness, or swelling of the inside of the cheeks. These effects should go away when
treatment is stopped.
Other side effects that may occur:
• Temporary staining of the tongue. This disappears when treatment is stopped.
• Temporary staining of teeth. This can normally be removed by brushing. You can avoid
staining by not drinking tea, coffee or red wine – especially one hour after use, and by
brushing daily with toothpaste (see How to use). If staining continues it can be removed
with a scale & polish from your dentist or hygienist. You can clean your dentures with
denture cleaner.
• You may notice a change of taste or burning sensation when you first use the
mouthwash. This usually goes away with continued use.

1.3.1 Label-Leaflet
November 2013

PL 00079/0677
GlaxoSmithKline Consumer Healthcare

If peeling of the skin inside the mouth occurs, dilute the mouthwash with an equal
amount of water.

If you do get any side effects, even those not mentioned above, tell your doctor, dentist or
Storage and further information
Keep out of the reach and sight of children.
Do not use after the ‘EXP’ date shown on the pack.
Store below 25°C.
Use within 3 months of opening.
Active ingredient: Chlorhexidine Digluconate 0.2% w/v.
Other ingredients: Glycerol, macrogolglycerol hydroxystearate, sorbitol liquid (noncrystallising), peppermint flavour and purifying water.
Macrogolglycerol hydroxystearate may cause skin reactions.
MA Holder: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K. and all
enquiries should be sent to this address.
The manufacturer is Omega Pharma Manufacturing GmbH & Co. KG, Herrenberg,
PL 00079/0677
Text prepared: 11/2013

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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.