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ULTRACARE TOPICAL ANAESTHETIC GEL

Active substance(s): BENZOCAINE

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ULTRACARE® TOPICAL ANAESTHETIC GEL
Benzocaine 17.9% w/w

SU3704P

Read all of this leaflet carefully because it contains important
information for you.
Ultracare Topical Anaesthetic Gel will be applied at your dental surgery as part
of your dental treatment. It is available without a prescription.
Keep this leaflet. You may need to read it again
Ask your dentist if you need more information or advice
You must contact your dentist if your symptoms worsen or do not improve
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your dentist, doctor or pharmacist
In this leaflet:
1. What Ultracare Topical Anaesthetic Gel is and what it is used for
2. Before Ultracare Topical Anaesthetic Gel is applied
3. How Ultracare Topical Anaesthetic Gel will be applied
4. Possible side effects
5. How to store Ultracare Topical Anaesthetic Gel
6. Further information

1. What Ultracare Topical Anaesthetic Gel is and what it is used for

The name of your medicine is Ultracare Topical Anaesthetic Gel. It is used to:
deaden the pain of minor dental procedures when no injection of
anaesthetic is required
reduce the pain caused by injection of dental anaesthetic into the gums

2. Before Ultracare Topical Anaesthetic Gel is applied

Do not undergo treatment with Ultracare Topical Anaesthetic Gel if:
You have had an allergic (hypersensitive) reaction such as rash, itching or
wheezing to benzocaine or any of the other ingredients of Ultracare Topical
Anaesthetic Gel (see section 6 for other ingredients)
You have methaemoglobinaemia (a rare blood disorder that reduces the
ability of blood to carry oxygen). Symptoms are extreme tiredness, difficulty
in breathing and/or skin becomes slightly blue in colour
If you are not sure if the above applies to you, talk to your dentist or
healthcare professional before treatment begins.
Take special care with Ultracare Topical Anaesthetic Gel
Check with your dentist before undergoing treatment with Ultracare Topical
Anaesthetic Gel:
If you have phenylketonuria, a rare condition preventing your body breaking
down the chemical phenylalanine in your blood
If you have or have had an allergic reaction to any other local anaesthetic
If you have or have had an allergic reaction to a sunscreen product
If you are not sure if the above applies to you, talk to your dentist or healthcare
professional before treatment begins.
Taking other medicines
Please tell your dentist or healthcare professional:
If you are taking or have recently taken any other medicines, including
medicines obtained without prescription and herbal medicines
If you are taking or have recently taken sulphonamide antibiotics such as
co-trimoxazole for an infection
Pregnancy and breast-feeding
Ultracare Topical Anaesthetic Gel should not be used if you are pregnant,
think you may be pregnant or are breast-feeding. It should only be used if it is
considered essential by your dentist.
Driving and using machines
Ultracare Topical Anaesthetic Gel has no known effect on the ability to drive or
operate machinery. However if you feel very tired do not drive or operate any
machinery.
Important information about some of the ingredients
The colouring agent Allura Red (E129) may cause allergic type reactions
Aspartame contains a source of phenylalanine. This may be harmful if you
have phenylketonuria

3. How Ultracare Topical Anaesthetic Gel will be applied

Your dentist or healthcare professional will apply Ultracare Topical Anaesthetic
Gel to those areas of your mouth and gums where local anaesthesia is needed.
Applying this medicine
Depending on the size of area to be treated, your dentist or healthcare
professional will apply 0.2-0.5 ml of the gel to the area with an applicator.
The gel is rubbed into the lining of the mouth or the gums
The gel should start to work within 10 to 30 seconds and cause a tingling
followed by numbness where it was applied. The numbness will usually
last for only 5 to 10 minutes and will wear off shortly after your dental
treatment has finished
If you receive more Ultracare Topical Anaesthetic Gel than you should
The medicine will only be administered in the dental surgery under the
direction of a dentist or healthcare professional, and therefore taking too much
is extremely unlikely. If you feel you have received more gel than you should,
talk to a doctor, your dentist or go to a hospital straight away.

4. Possible side effects

Like all medicines, Ultracare Topical Anaesthetic Gel can cause side effects,
although not everybody gets them.
Contact your dentist or doctor immediately if any of the following occur:
Allergic reactions such as burning or stinging sensation on application,
shortness of breath, swelling of the face, lips, tongue, eyes or throat, rash
Feel very tired, have difficulty in breathing and/or your skin becomes slightly
blue in colour. These are symptoms of a serious condition called
methaemoglobinaemia
Reporting of side effects
If you get any side effects, talk to your dentist, 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.

5. How to store Ultracare Topical Anaesthetic Gel

Your dentist or healthcare professional knows how to store this medicine
properly (see section 6).

6. Further information

What Ultracare Topical Anaesthetic Gel contains

Ultracare Topical Anaesthetic Gel contains 17.9% w/w of benzocaine as the
active ingredient. This is equivalent to 6g of benzocaine per 30ml pack
Other ingredients include macrogols, glycerol, ethanol, aspartame, sodium
saccharin, titanium dioxide (E171), Allura Red (E129) and flavouring
What Ultracare Topical Anaesthetic Gel looks like and contents of the pack
Ultracare Topical Anaesthetic Gel is a pink, bubble-gum flavoured dental gel
for topical use on gums and in the mouth
Ultracare Topical Anaesthetic Gel is available in a 30ml bottle
Marketing Authorisation Holder: Optident Ltd, International Development
Centre, Valley Drive, Ilkley, West Yorkshire, LS29 8AL, United Kingdom.
Manufacturer: Laleham Health and Beauty Limited, Sycamore Park, Mill Lane
Alton, Hampshire, GU34 2PR, United Kingdom.
MA Number: PL 12139/0003
Leaflet last revised: May 2015

The following information is intended for the Dentist or
Healthcare Professional

How to prepare and administer Ultracare Topical Anaesthetic Gel
Aseptic techniques must be used when administering this medicine.

Method of Administration

1. Using a suitable unidose syringe, extract the required dose (normally 0.2 0.5 ml depending on the area to be anaesthetised) from the bottle of
Ultracare Topical Anaesthetic Gel.

2. Express the gel from the unidose syringe onto a clean cotton bud applicator.

3. Ensure the full dose is dispensed.

4. Vacuum excess saliva from mouth.

5. Apply the gel to the area to be anaesthetised using the cotton bud applicator.
Discard the cotton bud applicator after single use.
Take the following measures to help prevent cross-contamination of
the bottle:

Use a new unidose syringe per administration per patient
Dispose of the unidose syringe following use
Do not place the cotton bud applicator directly into the gel
Replace the bottle cap immediately after each use
Dispose of the unidose syringe in clinical waste if it is touched by used gloves
Storage

Do not store above 25┬░C.

Keep out of the sight and reach of children.

Do not use Ultracare Topical Anaesthetic Gel after the expiry date which is
stated on the carton after EXP. The expiry date refers to the last day of
that month.

Once the bottle has been opened use within 14 days.

Do not use this Product if you notice any visible change in the appearance
of the gel.

Do not dispose of medicines via wastewater. Take care to follow
appropriate procedures for the management of healthcare waste.
These measures will help to protect the environment.

V13/2015

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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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