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DENTINOX TEETHING GEL

Active substance(s): CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE

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STUDIO DETAILS
Client: Dendron
Job No: 02550-15

T E E T HING GE L

Lidocaine hydrochloride, Cetylpyridinium chloride

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet, you may need to read it again. If you need more information
or advice speak to your health visitor, pharmacist or doctor.
IN THIS LEAFLET:
1. What Dentinox Teething Gel is and what it is used for
2. Before you use Dentinox Teething Gel
3. How to use Dentinox Teething Gel
4. Possible side effects
5. How to store Dentinox Teething Gel
6. Further information
1. WHAT DENTINOX TEETHING GEL IS AND WHAT IT IS USED FOR
Dentinox Teething Gel contains the active ingredients lidocaine and cetylpyridinium.
Lidocaine is one of a group of medicines called local anaesthetics, which numb pain.
Cetylpyridinium is an antiseptic that is used to treat minor wounds and minor infections
of the mouth.
Dentinox Teething Gel relieves teething pain and soothes the gums from birth onwards.
2. BEFORE YOU USE DENTINOX TEETHING GEL
You should not use Dentinox Teething Gel if your baby is allergic (hypersensitive)
to lidocaine, cetylpyridinium or any other ingredients (see list of ingredients in
Section 6). See a doctor at once if you notice the following: rash, swelling of the
face, neck, tongue or throat (severe allergic reaction).
DO NOT USE Dentinox Teething Gel if the seal on the nozzle is broken.
Taking other medicines
Please tell your doctor or pharmacist if your baby is taking, or has recently taken,
any other medicines, including medicines obtained without a prescription.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF DENTINOX TEETHING GEL
Dentinox Teething Gel contains sorbitol. If you have been told by your doctor that your
baby has an intolerance to some sugars, contact your doctor before using this product.
This medicine also contains small amounts of ethanol, less than 100mg per dose.

Version No: V6
Date: 09/05/2016
Originator:
Steve Holman
Amended by:
Dave Simpson
Description:
Dentinox Teething Gel
PIL – LTD0159
TA:

N/A

Trim: 165 x 120 mm
Bleed: 3 mm
% of actual size: 100%
Barcode: N/A
Data Matrix: P0348
Colour:
PMS 3285
20% CYAN

brayleino.co.uk
Filleigh / Barnstaple / Bristol / London

01598 760 700
Accurate for content only. Refer to
printers proofs for colour matching.

3. HOW TO USE DENTINOX TEETHING GEL
Place a small quantity of Dentinox Teething Gel on a pad of cotton wool or a clean
fingertip and rub gently on the baby’s gum. Repeat after 20 minutes if necessary.
Use when necessary during the teething period.
If you have any further questions on the use of this product, speak to your health visitor,
pharmacist or doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dentinox Teething Gel can cause side effects, although these do not affect everybody.
There are no known side effects from Dentinox Teething Gel.
Reporting of side effects. If your baby experiences any side effects, consult your doctor or pharmacist.
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.
5. HOW TO STORE DENTINOX TEETHING GEL
Dentinox Teething Gel should be kept out of the sight and reach of children.
Do not store above 25°C.
Do not use Dentinox Teething Gel after the expiry date as indicated on the box.
The expiry date refers to the last day of the month.
Medicine should not be disposed of in waste-water or with household waste.
Ask your pharmacist what you should do with medications you no longer need.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Dentinox Teething Gel contains: The active substances are
lidocaine hydrochloride 0.33% w/w and cetylpyridinium chloride 0.10% w/w.
The other ingredients are: sorbitol solution 70% (non-crystallising),
xylitol, ethanol, glycerol, hydroxethylcellulose, polyoxyl 40 hydrogenated castor
oils, pharmaceutical liquid flavour, hydroxypolyethoxydodecane, macrogol 300,
sodium saccharin, caramel (E150), levomenthol and purified water.
What Dentinox Teething Gel looks like and contents of the pack:
Dentinox Teething Gel is available in aluminium tubes containing 10g or 15g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
DDD Limited, 94 Rickmansworth Road, Watford, Hertfordshire, United Kingdom, WD18 7JJ.
This leaflet was last revised in August 2015.

LTD0159

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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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