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.

• 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.

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.

•    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.

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?

•    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.

16. INFORMATION IN BRAILLE

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

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