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SENSODYNE TOTAL CARE F TOOTHPASTE

Active substance(s): POTASSIUM NITRATE / SODIUM FLUORIDE / POTASSIUM NITRATE / SODIUM FLUORIDE / POTASSIUM NITRATE / SODIUM FLUORIDE

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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.


6.

METHOD AND ROUTE(S) OF ADMINISTRATION
Use twice a day and not more than three times, instead of an ordinary toothpaste.

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.


6.

METHOD AND ROUTE(S) OF ADMINISTRATION
Use twice a day and not more than three times, instead of an ordinary toothpaste.

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 >

Expand Transcript

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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