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ORALDENE

Active substance(s): HEXETIDINE

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31/05/2016

09:46

Oraldene 200 ml
Component number:
JNJ LQ402001
Version: 9.0
CRD
Dimensions: 50 x ORALDENE
90 mm ORIGINAL 200ML UK
Client code: 16-0177
Minimum font size: 8 pts

STAMPING MENTIONS AREA
preprinted text
printed on line figures

F309420
9.0
LABEL
50 x 90 mm
ETQ015
Datamatrix LQ402001
NA
NA
16-0177
NA
Frutiger Condensed
8 pts
CYAN
MAGENTA
PMS 877
BLACK
Varnish free
NA

LOT

XXXXX

CONTENTS: The solution contains Hexetidine
0.1g/100 ml. Other ingredients: Polysorbate 80,
citric acid, saccharin sodium, levomenthol,
eucalyptus oil, ethanol 96%, azorubin (E122)
sodium calcium edetate, sodium hydroxide (E524),
and purified water.
Sodium content: 0.016 g/100 ml.
Oraldene has an antibacterial and antifungal action
which relieves mouth and throat infections,
including: mouth ulcers • sore and bleeding
gums • symptoms of sore throats • bad breath
Oraldene can also be used before and after dental
surgery.
Read and retain carton for full instructions.
Oraldene is a registered trade mark.
PL holder: McNeil Products Ltd, Maidenhead,
Berkshire, SL6 3UG, UK.
PL 15513/0067
MA 100/00401

EXP

mm/yyyy

Hexetidine

Medicated Relief for
Mouth & Throat
Infections

Do not use if bottle
seal is broken when
purchased.
Keep out of the
sight and reach of children.
DIRECTIONS: Mouthwash for
topical use only. DO NOT SWALLOW.
SHAKE WELL BEFORE USE.
ADULTS AND CHILDREN 6 YEARS
AND OLDER
Rinse the mouth or gargle for
30 seconds with at least 15 ml (approx.
1 tablespoonful) of undiluted Oraldene
two to three times a day. CHILDREN
UNDER 6 YEARS - not recommended.
If symptoms persist discontinue
treatment and consult your doctor or
dentist.
• Do not dilute.
• Do not store above 30°C.
Use within 6 months of opening.
Keep the bottle in the outer carton in
order to protect from light.

LQ402001-16-0177

LQ402001

EXP

1

Antibacterial
Mouthwash to relieve

gingivitis mouth ulcers
sore gums sore throat

200 ml

LOT

LQ402001-LAB ORALDENE ORIGINAL 200MLv9.0.pdf

1

14/06/2016

08:22

typesR

mm/yyyy

oraldene

LOT

LE303801-FB ORALDENE ORIGINAL 200MLv10.3.pdf

EXP

200 ml

Oraldene 200 ml
Component number:
JNJ LE303801
Version: 10.3
CRD
Dimensions: 60 x ORALDENE
60 x 136
mm 200ML UK
ORIGINAL
Code: 16-0176
Minimum font size: 7.5 pts

Medicated Relief for
Mouth & Throat Infections
Hexetidine

LE303801
16-0176

LE303801
F309419

10.3
FOLDING BOX
60 x 60 x 136 mm

Possible side-effects

ETU033
Datamatrix LE303801
NA

Hexetidine

How to use this medicine
EAN
16-0176
NA
Frutiger Bold
7.5 pts
CYAN
MAGENTA
PMS 877
BLACK
Varnish free
Braille
NA

Check the table below to see how much medicine
to use.
Oraldene is for topical use only, which means that
it should not be swallowed or taken internally.

Hexetidine

Medicated Relief for
Mouth & Throat Infections

i Children under 6 years old

Oraldene is not recommended for children under 6
years of age.

Reporting of side-effects

i Adults and Children aged 6 years and

If you get any side-effects, talk to your doctor,
pharmacist or nurse. This includes any possible sideeffects 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.

over

Age

Dose

Adults and
children
aged 6 years
and over

Rinse the mouth or gargle for
30 seconds with at least 15 ml
(approx. 1 tablespoonful) of
undiluted Oraldene two to three
times a day or as otherwise directed.

Do not dilute.
■ Do not swallow.
■ Shake well before use.


! If anyone accidentally swallows this
product

If anyone accidentally swallows this product,
contact a doctor or your nearest Accident and
Emergency department (Casualty) taking this
pack with you.

Oraldene can have side-effects, like all medicines,
although these don’t affect everyone and are
usually mild.
If you experience the following, stop using the
medicine and talk to your doctor:
■ Swelling of the face, lips, mouth, tongue or throat
which may cause difficulty in swallowing or
breathing ■ Allergic reactions including itchy rash
■ Irritation, tingling or numbness of the tongue
and/or tissues inside the mouth ■ Shortness of
breath ■ Cough ■ Dry mouth ■ Feeling sick (nausea)
■ Sickness (vomiting) ■ Salivary gland enlargement
■ Taste disturbance or loss of taste ■ Pain, swelling,
redness or heat ■ Tongue or tooth discolouration
■ Blistering or ulceration
If you get any side effects, talk to your doctor,
pharmacist or nurse.

Antibacterial
Mouthwash
to relieve

gingivitis
mouth ulcers
sore gums
sore throat

! If you forget to use the medicine

Storing this medicine

Do not use if bottle seal is broken when purchased.
Do not store above 30°C.
Use within 6 months of opening.
Keep the bottle in the outer carton in order to
protect from light.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the label. The expiry date refers
to the last day of that month.
Retain carton for full instructions.
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.

Further information

Use the next dose as soon as you remember
unless it is time to use it again. Do not use two
quantities in one go.

What’s in this medicine?

200 ml

The active ingredient is: Hexetidine 0.1 g/100 ml
Other ingredients are: Polysorbate 80, citric acid,
saccharin sodium, levomenthol, eucalyptus oil, ethanol
96%, azorubin (E122) sodium calcium edetate, sodium
hydroxide (E524), and purified water.

What the medicine looks like

Oraldene is a clear red solution available in 200 ml
bottles. It contains 0.1 g of the active ingredient in
every 100 ml of medicine.

What the medicine is for
The mouthwash contains hexetidine, which is an
antibacterial and antifungal and is used to help
treat throat and mouth infections, including
mouth ulcers, thrush, sore or bleeding gums
(called gingivitis), bad breath (halitosis) or sore
throat. It can also be used before and after dental
surgery to help prevent infections.

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

Do not use this medicine…
■ If

you have ever had a bad reaction to
Oraldene or any of its ingredients. If this
applies to you, get advice from your doctor
or pharmacist without using Oraldene.
■ If your symptoms persist talk to your doctor
or pharmacist.

If you are pregnant or breast-feeding
■ Ask

your doctor or pharmacist for advice
before using Oraldene if you are pregnant or
breast-feeding.

Some of the ingredients can cause
problems
■ Ethanol

(96%) may cause irritation or dry
skin if frequently applied to the skin.
■ Azorubin (E122) can cause allergic reactions,
including asthma. Reactions are more
common in people who are allergic to aspirin.
■ Sodium content: 0.016 g/100 ml.
This carton was revised June 2016. ©
Oraldene is a registered trade mark.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.

PL 15513/0067
MA 100/00401

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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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