Medine.co.uk

Sensodyne Total Care F Toothpaste

Document: label-leaflet MAH BRAND_PL 44673-0064 change

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON


1. NAME OF THE MEDICINAL PRODUCT


SENSODYNE® Total Care F Toothpaste

Potassium Nitrate, Sodium Fluoride


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Active ingredients: Potassium Nitrate 5% w/w and Sodium Fluoride 0.306% w/w (1400 ppm fluoride).


3. LIST OF EXCIPIENTS


Other ingredients: Sorbitol, glycerol, silica dental type, purified water, sodium laurilsulfate, titanium dioxide (E 171), saccharin sodium, mint flavour 826473, cocamidopropyl betaine, xanthan gum and macrogol.


4. PHARMACEUTICAL FORM AND CONTENTS


Toothpaste 45 ml


5. METHOD AND ROUTE(S) OF ADMINISTRATION


• Use twice a day 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 AND SIGHT OF CHILDREN


Keep out of the reach and sight of children.


7. OTHER SPECIAL WARNING(S), IF NECESSARY


POSSIBLE SIDE EFFECTS

Sensodyne Total Care F 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 very rare.

•    If you do get any side effects, even those not mentioned above, tell your doctor, dentist or pharmacist.

CHECK BEFORE YOU USE

•    Do not use Sensodyne Total Care F if you have ever had an allergic reaction to

potassium nitrate, sodium fluoride or any of the other ingredients (see Further Information).

•    Sensitive teeth may indicate an underlying problem that needs prompt care. If symptoms persist or worsen see your dentist.

•    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using.

Do not use if carton ends are open

•    Always follow the label directions.

•    For dental use only. If irritation occurs, discontinue use.

•    Not for use by children under 12 years of age unless on advice of a dental professional or doctor.

8. EXPIRY DATE


EXP:

9. SPECIAL STORAGE CONDITIONS


HOW TO STORE SENSODYNE TOTAL CARE F

Store below 30°C.

Do not use after the EXP date shown on the end of the carton. Use within 6 months of opening.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL

PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


< not applicable >

11.    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER


The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

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

Sensodyne and the rings device are registered trade marks owned by or licensed to the GSK group of companies.

[Company logo]


12. MARKETING AUTHORISATION NUMBER(S)


PL 44673/0064


13. BATCH NUMBER


BN:


14.    GENERAL CLASSIFICATION FOR SUPPLY_

< not applicable - GSL >

15.    INSTRUCTIONS ON USE_

SENSODYNE® Total Care F 24/7 CARE FOR SENSITIVE TEETH

CLINICALLY PROVEN RELIEF FROM THE PAIN OF SENSITIVE TEETH

FURTHER INFORMATION

Text revised: July 2016.


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 heat, cold, sweetness, acidity or brushing.

WHAT SENSODYNE TOTAL CARE F TOOTHPASTE DOES

Sensodyne Total Care F Toothpaste has a mint taste.

The toothpaste contains two active ingredients. Potassium nitrate is clinically proven to prevent and relieve the pain of sensitive teeth by directly calming the nerve endings inside your teeth. Sodium fluoride helps prevent tooth decay (including the vulnerable areas where gums have receded). Sensodyne Total Care F also has an antibacterial action and regular brushing promotes healthy gums.

HOW TO USE SENSODYNE TOTAL CARE F

The ends of this carton have been glued down.

16. INFORMATION IN BRAILLE


< not applicable - none currently registered >

PARTICULARS TO APPEAR ON THE INNER PACKAGING TUBE


1. NAME OF THE MEDICINAL PRODUCT


SENSODYNE® Total Care F Toothpaste

Potassium Nitrate, Sodium Fluoride


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Active ingredients: Potassium Nitrate 5% w/w and Sodium Fluoride 0.306% w/w (1400 ppm fluoride).


3. LIST OF EXCIPIENTS


Other ingredients: Sorbitol, glycerol, silica dental type, purified water, sodium laurilsulfate, titanium dioxide (E 171), saccharin sodium, mint flavour 826473, cocamidopropyl betaine, xanthan gum and macrogol.


4. PHARMACEUTICAL FORM AND CONTENTS


Toothpaste 45 ml


5. METHOD AND ROUTE(S) OF ADMINISTRATION


HOW TO USE SENSODYNE TOTAL CARE F

• Use twice a day 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 AND SIGHT OF CHILDREN


Keep out of the reach and sight of children.


7. OTHER SPECIAL WARNING(S), IF NECESSARY


CHECK BEFORE YOU USE

• Sensitive teeth may indicate an underlying problem that needs prompt care. If symptoms persist or worsen see your dentist.


•    Always follow the label directions.

•    For dental use only. If irritation occurs, discontinue use.

•    Not for use by children under 12 years of age unless on advice of a dental professional or doctor.


8. EXPIRY DATE


EXP:


9. SPECIAL STORAGE CONDITIONS


HOW TO STORE SENSODYNE TOTAL CARE F

Store below 30°C.

Do not use after the EXP date shown on the end of the tube. Use within 6 months of opening.


10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL

PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


< not applicable >


11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

Sensodyne and the rings device are registered trade marks owned by or licensed to the GSK group of companies.

[Company logo]


12. MARKETING AUTHORISATION NUMBER(S)


PL 44673/0064


13. BATCH NUMBER


BN:


14. GENERAL CLASSIFICATION FOR SUPPLY


< not applicable - GSL >


15. INSTRUCTIONS ON USE


24/7 CARE FOR SENSITIVE TEETH

CLINICALLY PROVEN RELIEF FROM THE PAIN OF SENSITIVE TEETH Sensodyne Total Care F Toothpaste has a mint taste.

The toothpaste contains potassium nitrate, which is clinically proven to prevent and relieve the pain of sensitive teeth. This active ingredient directly calms the nerve endings inside your teeth. Sodium fluoride helps prevent tooth decay (including the vulnerable areas where gums have receded). Sensodyne Total Care F also has an antibacterial action and regular brushing promotes healthy gums.

FURTHER INFORMATION


16. INFORMATION IN BRAILLE


< not applicable >


PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON


1. NAME OF THE MEDICINAL PRODUCT


SENSODYNE® Total Care F Toothpaste

Potassium Nitrate, Sodium Fluoride


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Active ingredients: Potassium Nitrate 5% w/w and Sodium Fluoride 0.306% w/w (1400 ppm fluoride).


3. LIST OF EXCIPIENTS


Other ingredients: Sorbitol, glycerol, silica dental type, purified water, sodium laurilsulfate, titanium dioxide (E 171), saccharin sodium, mint flavour 826473, cocamidopropyl betaine, xanthan gum and macrogol.


4. PHARMACEUTICAL FORM AND CONTENTS


Toothpaste


75 ml 100 ml


5. METHOD AND ROUTE(S) OF ADMINISTRATION


• Use twice a day 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 AND SIGHT OF CHILDREN


Keep out of the reach and sight of children.


7. OTHER SPECIAL WARNING(S), IF NECESSARY


POSSIBLE SIDE EFFECTS

Sensodyne Total Care F 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 very rare.

•    If you do get any side effects, even those not mentioned above, tell your doctor, dentist or pharmacist.

CHECK BEFORE YOU USE

•    Do not use Sensodyne Total Care F if you have ever had an allergic reaction to

potassium nitrate, sodium fluoride or any of the other ingredients (see Further Information).

•    Sensitive teeth may indicate an underlying problem that needs prompt care. If symptoms persist or worsen see your dentist.

•    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using.

Do not use if carton ends are open

•    Always follow the label directions,

•    For dental use only. If irritation occurs, discontinue use.

•    Not for use by children under 12 years of age unless on advice of a dental professional or doctor.

8. EXPIRY DATE


EXP:

9. SPECIAL STORAGE CONDITIONS


HOW TO STORE SENSODYNE TOTAL CARE F

Store below 30°C.

Do not use after the EXP date shown on the end of the carton. Use within 6 months of opening.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL

PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


< not applicable >

11.    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER


The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

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

Sensodyne and the rings device are registered trade marks owned by or licensed to the GSK group of companies.

[Company logo]


12. MARKETING AUTHORISATION NUMBER(S)


PL 44673/0064


13. BATCH NUMBER


BN:


14.    GENERAL CLASSIFICATION FOR SUPPLY_

< not applicable - GSL >

15.    INSTRUCTIONS ON USE_

SENSODYNE® Total Care F 24/7 CARE FOR SENSITIVE TEETH

CLINICALLY PROVEN RELIEF FROM THE PAIN OF SENSITIVE TEETH

FURTHER INFORMATION

Text revised: July 2016.


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 heat, cold, sweetness, acidity or brushing.

WHAT SENSODYNE TOTAL CARE F TOOTHPASTE DOES

Sensodyne Total Care F Toothpaste has a mint taste.

The toothpaste contains two active ingredients. Potassium nitrate is clinically proven to prevent and relieve the pain of sensitive teeth by directly calming the nerve endings inside your teeth. Sodium fluoride helps prevent tooth decay (including the vulnerable areas where gums have receded). Sensodyne Total Care F also has an antibacterial action and regular brushing promotes healthy gums.

HOW TO USE SENSODYNE TOTAL CARE F

The ends of this carton have been glued down.

16. INFORMATION IN BRAILLE


< not applicable - none currently registered >

PARTICULARS TO APPEAR ON THE INNER PACKAGING TUBE


1. NAME OF THE MEDICINAL PRODUCT


SENSODYNE® Total Care F Toothpaste

Potassium Nitrate, Sodium Fluoride


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Active ingredients: Potassium Nitrate 5% w/w and Sodium Fluoride 0.306% w/w (1400 ppm fluoride).


3. LIST OF EXCIPIENTS


Other ingredients: Sorbitol, glycerol, silica dental type, purified water, sodium laurilsulfate, titanium dioxide (E 171), saccharin sodium, mint flavour 826473, cocamidopropyl betaine, xanthan gum and macrogol.


4. PHARMACEUTICAL FORM AND CONTENTS


Toothpaste


75 ml 100 ml


5. METHOD AND ROUTE(S) OF ADMINISTRATION


HOW TO USE SENSODYNE TOTAL CARE F

• Use twice a day 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 AND SIGHT OF CHILDREN


Keep out of the reach and sight of children.


7. OTHER SPECIAL WARNING(S), IF NECESSARY


CHECK BEFORE YOU USE

• Sensitive teeth may indicate an underlying problem that needs prompt care. If symptoms persist or worsen see your dentist.


•    Always follow the label directions.

•    For dental use only. If irritation occurs, discontinue use.

•    Not for use by children under 12 years of age unless on advice of a dental professional or doctor.


8. EXPIRY DATE


EXP:


9. SPECIAL STORAGE CONDITIONS


HOW TO STORE SENSODYNE TOTAL CARE F

Store below 30°C.

Do not use after the EXP date shown on the end of the tube. Use within 6 months of opening.


10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL

PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


< not applicable >


11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

Sensodyne and the rings device are registered trade marks owned by or licensed to the GSK group of companies.

[Company logo]


12. MARKETING AUTHORISATION NUMBER(S)


PL 44673/0064


13. BATCH NUMBER


BN:


14. GENERAL CLASSIFICATION FOR SUPPLY


< not applicable - GSL >


15. INSTRUCTIONS ON USE


24/7 CARE FOR SENSITIVE TEETH

CLINICALLY PROVEN RELIEF FROM THE PAIN OF SENSITIVE TEETH

Sensodyne Total Care F Toothpaste has a mint taste. The toothpaste contains potassium nitrate, which is clinically proven to prevent and relieve the pain of sensitive teeth. This active ingredient directly calms the nerve endings inside your teeth. Sodium fluoride helps prevent tooth decay (including the vulnerable areas where gums have receded). Sensodyne Total Care F also has an antibacterial action and regular brushing promotes healthy gums.

FURTHER INFORMATION


16. INFORMATION IN BRAILLE


< not applicable >