PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1. NAME OF THE MEDICINAL PRODUCT
Duraphat® 500mg/100g Toothpaste Fluoride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
1 g of toothpaste contains 5 mg Fluoride (as Sodium Fluoride), corresponding to 5000 ppm Fluoride.
3. LIST OF EXCIPIENTS
Excipients: Liquid Sorbitol (Non-crystallising), Dental Type Silica, Dental Type Silica (Precipitated), Macrogol 600, Tetrapotassium Pyrophosphate, Xanthan Gum, Sodium Benzoate (E211), Sodium Laurilsulfate, Spearmint flavouring (containing Peppermint Oil, Carvone, Spearmint Oil, Menthol, Anethol, and Lemon Oil), Saccharin Sodium, Brilliant Blue FCF (E133), and Purified Water.
4. PHARMACEUTICAL FORM AND CONTENTS
Toothpaste 51g [3x51g]
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Dental Use Do not swallow Read the package leaflet before use.
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
Do not use in adolescents and children under 16 years of age. Contains Sodium Benzoate.
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8. EXPIRY DATE
EXP {MM/YYYY}
9. SPECIAL STORAGE CONDITIONS
Do not store above 25C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE n/a
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
<[To be completed nationally]>
12. MARKETING AUTHORISATION NUMBER(S)
<[To be completed nationally]>
13 BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
<[To be completed nationally]>
15. INSTRUCTIONS ON USE
[P:] For the prevention of dental caries (tooth decay) in adolescents aged 16 years and over and adults, particularly amongst patients at risk from multiple caries (coronal and/or root caries).
Instructions on use: Brush teeth carefully using a 2 cm ribbon of Duraphat® Toothpaste for approximately 3 minutes, 3 times daily after each meal. Brush vertically from gum to tip. Spit out excess foam and do not swallow.
[POM:] n/a
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16. INFORMATION IN BRAILLE
<[To be completed nationally]>
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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1. NAME OF THE MEDICINAL PRODUCT
Duraphat® 500mg/100g Toothpaste Fluoride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
1 g of toothpaste contains 5 mg Fluoride (as Sodium Fluoride), corresponding to 5000 ppm Fluoride.
3. LIST OF EXCIPIENTS
Excipients: Liquid Sorbitol (Non-crystallising), Dental Type Silica, Dental Type Silica (Precipitated), Macrogol 600, Tetrapotassium Pyrophosphate, Xanthan Gum, Sodium Benzoate (E211), Sodium Laurilsulfate, Spearmint flavouring (containing Peppermint Oil, Carvone, Spearmint Oil, Menthol, Anethol, and Lemon Oil), Saccharin Sodium, Brilliant Blue FCF (E133), and Purified Water.
4. PHARMACEUTICAL FORM AND CONTENTS
Toothpaste 51g [3x51g]
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Dental Use Do not swallow Read the package leaflet before use.
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
Do not use in adolescents and children under 16 years of age. Contains Sodium Benzoate.
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8. EXPIRY DATE
EXP {MM/YYYY}
9. SPECIAL STORAGE CONDITIONS
Do not store above 25C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE n/a
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
<[To be completed nationally]>
12. MARKETING AUTHORISATION NUMBER(S)
<[To be completed nationally]>
13 BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
<[To be completed nationally]>
15. INSTRUCTIONS ON USE
[P:] For the prevention of dental caries (tooth decay) in adolescents aged 16 years and over and adults, particularly amongst patients at risk from multiple caries (coronal and/or root caries).
Instructions on use: Brush teeth carefully using a 2 cm ribbon of Duraphat® Toothpaste for approximately 3 minutes, 3 times daily after each meal. Brush vertically from gum to tip. Spit out excess foam and do not swallow.
[POM:] n/a
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16. INFORMATION IN BRAILLE
<[To be completed nationally]>
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