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. EXP:
EXPIRY DATE
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. BN:
BATCH NUMBER
14. GSL
GENERAL CLASSIFICATION FOR SUPPLY
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.
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. EXP:
EXPIRY DATE
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. BN:
BATCH NUMBER
14. GSL
GENERAL CLASSIFICATION FOR SUPPLY
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.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
