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CALGEL TEETHING GEL

Active substance(s): CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE

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2 Before giving the
medicine to your child

3 How to use this medicine


This medicine is suitable for most children, but a few
children should not use it. If you are in any doubt, talk
to your doctor or pharmacist.



Babies under 3 months
This medicine is not recommended for babies under
3 months.

Do not give your child this medicine…


This medicine provides relief from the symptoms of

teething pain.
■ The medicine is OK for most babies and toddlers over
3 months.
■ Do not give it to anyone on this list:
■ Not to anyone who has ever had a bad reaction to
any of the ingredients. See section 6 ➤
■F
 ollow the dosage instructions carefully. These are
shown in the table. See section 3 ➤
Now read this whole leaflet carefully before you
use this medicine. Keep the leaflet: you might need it
again.

1 What the medicine is for
CALGEL® Teething Gel provides relief from the symptoms
of teething pain. The lidocaine (a local anaesthetic) in
the CALGEL® Teething Gel is used to help relieve teething
pain and soothe infants' and toddlers' gums. It also
contains cetylpyridium chloride (a mild antiseptic) to help
prevent infection.

LN509101_PIL CALGEL TEETHING GEL 10G UKv9.7.indd 1



If s/he has ever had an allergic reaction to the
product, chamomile, or any of the ingredients.

If this applies, get advice from a doctor or
pharmacist without using CALGEL®.

Talk to your doctor or pharmacist…


If your child has an intolerance to some sugars.

If this bullet point applies now or in the past, speak
to a doctor or pharmacist.

Babies from 3 months and over
Age

Dose

Babies and
toddlers
3 months
and over

Approximately one-third
of an inch (7.5 mm).
Place the quantity of gel onto a
clean pad of cotton wool or the tip
of a clean finger and gently rub
onto the affected area of the gum.

If your child is using any other medicines
No interactions with other medicines are currently known.

If you are pregnant or breast-feeding
The following advice is included in case an older
child or adult is taking this medicine.
■ If you are pregnant or breast-feeding only use
this medicine on the advice of your doctor.

Some of the ingredients can cause problems
T his product contains sorbitol. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking
this medicinal product.
■ This product contains small amounts of ethanol
(alcohol), less than 100 mg per dose.
■ Xylitol may have a laxative effect.
■ The castor oil may cause stomach upsets and
diarrhoea.


F or topical use only.
Do not give more than the dose stated below.




If necessary, repeat the dose after 20 minutes.
Do not use more than 6 times in one day.

If anyone has used too much
If anyone uses more CALGEL® Teething Gel than
they should, or if large quantities of the gel are
accidentally swallowed, contact a doctor or your
nearest Accident Emergency Department (Casualty)
taking this leaflet and pack with you, even if the
child seems well.

turn over

09/08/2017 11:30

4 Possible side-effects

5 Storing this medicine

CALGEL® Teething Gel can have side-effects, like all
medicines, although these are rare and usually mild.

Keep this medicine out of the sight and reach of children.

If your child experiences any of the following,
stop using the medicine and seek immediate
medical help:
S welling of the mouth, gums or tongue.
Difficulty in breathing.
■ Rash.
■ Inflammation of the skin.
■ Reddening of the skin.



Reporting of the side-effects
If you get any side-effects, talk to your doctor, pharmacist or
nurse. This includes any possible side-effects not listed in
this leaflet. 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.

Do not store above 25ºC.
Keep the tube tightly closed.
Store in the original package.
Do not use your medicine after the date shown as an
expiry date on the packaging.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

What the medicine looks like
CALGEL® Teething Gel is a yellowish-brown gel,
available in 10 g tubes.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans, 5 avenue de Concyr,
45071 Orléans, Cedex 2, France.
This leaflet was revised August 2017.
CALGEL® Teething Gel is a registered trade mark.

6 Further information
What’s in this medicine?
The active ingredients in CALGEL® Teething Gel are:
Lidocaine hydrochloride 0.33% w/w and Cetylpyridinium
chloride 0.10% w/w.
Other ingredients are: Sorbitol solution (70%) (E420),
xylitol (E967), ethanol 96%, glycerol, hydroxyethyl
cellulose 5000, macrogolglycerol hydroxystearate (castor
oil polyoxyl hydrogenated), macrogol lauryl
ether 9, macrogol 300, saccharin sodium, levomenthol,
pharmaceutical liquid flavour (containing chamomile),
caramel (E150), citric acid monohydrate, sodium citrate
dihydrate and purified water.

Component: LN509101, 16-0362
Version: 9.7
Dimension: 148x210mm
Date: 09/08/2017

Sorbitol content 15% w/w.

LN509101
16-0362

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09/08/2017 11:30

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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.

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