SENSODYNE MINT

Active substance: STRONTIUM ACETATE HEMIHYDRATE

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Carton

1.

NAME OF THE MEDICINAL PRODUCT

Sensodyne Mint / Macleans Sentitive
Strontium Acetate, Sodium Fluoride

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Active Ingredients: Strontium Acetate Hemihydrate 8% w/w and Sodium Fluoride 0.23%
w/w (1040 ppm fluoride).

3.

LIST OF EXCIPIENTS

Other Ingredients: Gycerol, sorbitol, xanthan gum, silica dental type, hydrated silicon
dioxixe, sodium N-methyl-N-cocyl taurate, titanium dioxide (E 171), sodium methyl
parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E 217), water, sodium
saccharin, menthol, peppermint oil, anethole, L-carvone, eucalyptol, L-menthone, L-menthyl
acetate and limonene.
Sodium methyl and sodium propyl parahydroxybenzoate may cause allergic reactions
(possibly delayed).

4.

PHARMACEUTICAL FORM AND CONTENTS

Toothpaste
17, 25, 45, 50, 55, 75 or 125 ml tubes.
100 ml pump.

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

HOW TO USE SENSODYNE MINT / MACLEANS SENSITIVE
The ends of this carton have been glued down. Do not use if carton ends are open.
x

Adults and children aged 12 years and over: Use Sensodyne Mint/Macleans Sensitive
twice daily and not more than three times instead of an ordinary toothpaste.

x

Not to be used by children under 12 years unless recommended by your dentist or
doctor.
6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE
STORED OUT OF THE REACH OF CHILDREN

HOW TO STORE MACLEANS SENSITIVE
Keep out of the reach and sight of children.
Always follow the label directions. As with any other oral care products, if irritation occurs
discontinue use.

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

POSSIBLE SIDE EFFECTS
Sensodyne Mint / Macleans Sensitive can have side effects, but not everybody gets them.
x

Stop using the toothpaste and talk to your dentist or doctor as soon as possible if you
experience swelling of the mouth or face. These may be symptoms of an allergic
reaction which is rare.
If you do get any side effects, even those not mentioned above, tell your doctor, dentist
or pharmacist.

x

8.

EXPIRY DATE

EXP:

9.

SPECIAL STORAGE CONDITIONS

10.

SPECIAL RPECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH
MEDICINAL PRODUCTS, IF APPROPRIATE

Do not use after the EXP date shown on the end of the carton.

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION
HOLDER

The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare, Brentford,
TW8 9GS U.K. and all enquiries should be sent to this address.
Sensdoyne and the rings device is a registered trade mark of the GSK group of companies.

12.

MARKETING AUTHORISATION NUMBER(S)

PL 00079/0225

13.

BATCH NUMBER

BN:

14.

GENERAL CLASSIFICATION FOR SUPPLY

GSL

15.

INSTRUCTION ON USE

WHAT IS TOOTH SENSITIVITY?
Teeth are protected by a hard layer of enamel. If this is damaged or worn away then the
dentine underneath is exposed and this can cause pain.
WHAT CAUSES SENSITIVE TEETH?
x
x
x

Receding gums exposing dentine at the gum line.
Erosion caused by fizzy, sweet and/or acidic drinks.
Wearing of enamel caused by over-enthusiastic brushing.

Any of these factors can make your teeth over-sensitive to hear, cold, sweetness, acidity or
brushing.
WHAT SENSODYNE MINT / MACLEANS SENSITIVE DOES
Sensodyne Mint/ Macleans Sensitive toothpaste contains strontium acetate, which is
clinically proven to relieve the pain of sensitive teeth. This active ingredient blocks the
openings in the surface of the exposed dentine. This stops the pain stimulus getting through to
the nerves of your teeth. Sodium fluoride helps prevent tooth decay, including the vulnerable
areas where gums have receded.

CHECK BEFORE YOU USE
Do not use Sensodyne Mint / Macleans Sensitive if you have ever had an allergic reaction
to strontium acetate, sodium fluoride or any of the other ingredients (see Further
Information).
Sensitive teeth may be caused by an underlying problem. Talk to your dentist as soon as
possible.
If you have ever been told by your doctor that you have an intolerance to some sugars,
contact your doctor before using.

16.

INFORMATION IN BRAILLE

Sensodyne Mint
Text revised: November 2013

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Tube

1.

NAME OF THE MEDICINAL PRODUCT

Sensodyne Mint / Macleans Sentitive
Strontium Acetate, Sodium Fluoride

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.
Sensodyne and the rings device is a registered trade mark of the GSK group of companies.

3.

EXPIRY DATE

< Printed at the time of manufacture >

4.

BATCH NUMBER

< Printed at the time of manufacture >

5.

OTHER

Sensodyne Mint / Macleans Sensitive toothpaste contains strontium acetate, which is
clinically proven to relieve the pain of sensitive teeth. This active ingredient blocks the
openings in the surface of the exposed dentine. This stops the pain stimulus getting through to
the nerves of your teeth. Sodium fluoride helps prevent tooth decay, including the vulnerable
areas where gums have receded.
CHECK BEFORE USE
x

Sensitive teeth may be caused by an underlying problem. Talk to your dentist as soon as
possible.

HOW TO USE MACLEANS SENSITIVE
x

Adults and children aged 12 years and over: Use Sensodyne Mint/Macleans Sensitive
twice daily and not more than three times instead of an ordinary toothpaste.

x

Not to be used by children under 12 years unless recommended by your dentist or
doctor.

HOW TO STORE MACLEANS SENSITIVE
Keep out of the reach and sight of children.
Do not use after the EXP date shown on the end of tube.
FURTHER INFORMATION
Active ingredients: Strontium Acetate Hemihydrates 8% w/w and Sodium Fluoride 0.23%
w/w (1040 ppm fluoride).
Other ingredients: Gycerol, sorbitol, xanthan gum, silica dental type, hydrated silicon
dioxixe, sodium N-methyl-N-cocyl taurate, titanium dioxide (E 171), sodium methyl
parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E 217), water, sodium
saccharin, menthol, peppermint oil, anethole, L-carvone, eucalyptol, L-menthone, L-menthyl
acetate and limonene.

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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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