Medication Guide App

SENSODYNE MINT

Active substance: STRONTIUM ACETATE HEMIHYDRATE

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Transcript
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Carton

1.

NAME OF THE MEDICINAL PRODUCT

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, precipitated silica,
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 allerig 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 MACLEANS SENSITIVE
The ends of this carton have been glued down. Do not use if carton ends are open.



Adults and children aged 7 years and over: Use Macleans Sensitive daily, morning and
night instead of an ordinary toothpaste.
Not to be used by children under 7 years unless recommended by your dentist.

6.

SPECIAL WAARNING 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.

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

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


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.



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.
The manufacturer is BCM Ltd, Nottingham, NG90 2PR, U.K.

Macleans is a registered trade mark of the GlaxoSmithKline 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?




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 MACLEANS SENSITIVE DOES
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 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

Macleans Sensitive

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Tube

1.

NAME OF THE MEDICINAL PRODUCT

Macleans Sentitive
Strontium Acetate, Sodium Fluoride

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.
Macleans Sensitive is a registered trade mark of the GlaxoSmithKline group of companies.

3.

EXPIRY DATE

< Printed at the time of manufacture >

4.

BATCH NUMBER

< Printed at the time of manufacture >

5.

OTHER

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


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

HOW TO USE MACLEANS SENSITIVE



Adults and children aged 7 years and over: Use Macleans Sensitive daily, morning and
night instead of an ordinary toothpaste.
Not to be used by children under 7 years unless recommended by your dentist.

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, precipitated silica,
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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