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Sodium Fluoride 2800 ppm Toothpaste – patient leaflet, side effects, dosage

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Patient leaflet - Sodium Fluoride 2800 PPM toothpaste

1. What Sodium Fluoride 2800 ppm Toothpaste is and what it is used for

Sodium Fluoride 2800 ppm Toothpaste is used to treat and help prevent dental caries (tooth decay) in children aged 10 years and over and adults, particularly amongst patients at risk from multiple caries. This toothpaste contains fluoride as sodium salt, which belongs to a group of medicines called caries preventing agents.

2. What you need to know before you use Sodium Fluoride 2800 ppm Toothpaste

Do not use Sodium Fluoride 2800 ppm Toothpaste

Ÿ If you are allergic (hypersensitive) to sodium fluoride or any of the other

ingredients of this medicine listed in section 6.

Ÿ If you are a child aged under 10 years.

Warnings and precautions

Talk to your doctor, dentist, or pharmacist before using Fluoride Toothpaste.

In order to prevent accumulation of fluoride, your total intake must be assessed before using this fluoride toothpaste. Ask your dentist, pharmacist or oral hygienist concerning this matter.

Children and adolescents

Sodium Fluoride 2800 ppm Toothpaste is not intended for use in children under 10 years old.

Other medicines and Sodium Fluoride 2800 ppm Toothpaste

No interactions with other medicines are known. Tell your dentist or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Sodium Fluoride 2800 ppm Toothpaste with food and drink

Fluoridated water and salt should be avoided during the use of this toothpaste.

Food and drink, if taken immediately after brushing, may have an inhibitory effect on the remineralisation of the teeth. Therefore brush your teeth with Sodium Fluoride 2800 ppm Toothpaste after meals.

Pregnancy, breast-feeding and fertility

There is no experience with the use of Sodium Fluoride in pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor, dentist or pharmacist for advice before using this toothpaste.

Driving and using machines

Sodium Fluoride 2800 ppm Toothpaste has no or negligible influence on the ability to drive or use machines.

Sodium Fluoride 2800 ppm Toothpaste contains sorbitol solution (E420), sodium benzoate (E211) and propylene glycol (E1520)

Ÿ This medicine contains 231 mg sorbitol solution (E420) in each 1 g.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Ÿ This medicine contains 1 mg sodium benzoate (E211) in each 1 g which is equivalent to 0.1 % w/w. Sodium benzoate may cause local irritation. Ÿ This medicine contains a maximum of 1.25 mg propylene glycol

(E1520) in each 1 g which is equivalent to 0.125% w/w. Propylene glycol may cause skin irritation.

3. How to use Sodium Fluoride 2800 ppm Toothpaste

Sodium Fluoride 2800 ppm Toothpaste is only for use by persons aged ten years and older.

Always use this medicine exactly as described in this leaflet or as your doctor, dentist, or pharmacist has told you. Check with your doctor, dentist or pharmacist if you are not sure.

Use daily instead of the normal toothpaste. Brush carefully and thoroughly, for one minute, morning and evening:

Ÿ apply a 1 cm ribbon of toothpaste onto the toothbrush for each brushing Ÿ brush teeth vertically, from the gum to the tip of the teeth Ÿ careful brushing takes approximately one minute

Ÿ Spit out excess foam and do not swallow

Ÿ for best results do not drink or rinse for 30 minutes

Use in children and adolescents

This toothpaste is not for use by children aged less than 10 years.

If you use more Sodium Fluoride 2800 ppm Toothpaste than you should, or if you have swallowed the toothpaste

If you swallow a large amount of toothpaste by mistake, and if you experience digestive problems such as: vomiting, diarrhoea, and abdominal pain, you must tell a doctor immediately as treatment may be required. Please take this leaflet with you.

If you constantly swallow too much of the toothpaste over several months and years, you may experience dental fluorosis (stained or speckled appearance of the dental enamel and enamel fragility) or bone fluorosis (osteosclerosis; increased density of your bones).

If you forget to use Sodium Fluoride 2800 ppm Toothpaste

Simply use as soon as you remember. Do not use a double dose to make up for a forgotten dose. Continue treatment as usual after the next meal.

If you have any further questions on the use of this product, ask your dentist or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In some rare cases (i.e. less than 1 in 1000 people treated) allergic (hypersensitivity) reactions can occur e.g. rash, itching swelling and redness.

Burning oral sensation has also been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, dentist or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sodium Fluoride 2800 ppm Toothpaste

Keep this medicine out of the sight and reach of children.

Place the cap back on the tube after use.

Do not use Sodium Fluoride Toothpaste after the expiry date which is stated on the tube and carton after "EXP". The expiry date refers to the last day of that month.

Discard 6 months after opening.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

0271/L-10

6. Contents of the pack and other Information

What Sodium Fluoride 2800 ppm Toothpaste contains

Ÿ The active substance is fluoride (as sodium fluoride). Each 1 g of toothpaste contains 2.8 mg fluoride (as sodium fluoride), corresponding to 2800 ppm fluoride.

Ÿ The other ingredients are glycerol (E422), sodium benzoate (E211), sorbitol solution (E420) (70%) (non-crystallising), precipitated silica, macrogol 600, sodium lauryl sulphate, carmellose sodium, mint flavour (propylene glycol (E1520)), titanium dioxide (E171), sodium saccharin (E954) and purified water.

What Sodium Fluoride 2800 ppm Toothpaste looks like and contents of the pack

Sodium Fluoride 2800 ppm Toothpaste is a white, smooth, semisolid homogenous paste.

75 ml of toothpaste filled in white coloured lami tube fitted with white coloured flip top cap enclosed in an outer carton.

Marketing Authorisation Holder

Dawa Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, United Kingdom.

Manufacturer

Drugsrus Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, United Kingdom.

This leaflet was last revised in August 2026.

Blind or partially sighted?

Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PL 30684/0271

Last revision stated in the text: August 2026 · MHRA data as of 13 October 2026

What the sections and the side effect frequencies mean: How to read a patient leaflet

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The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Sodium Fluoride 2800 PPM toothpaste

What these facts mean

Active substance? Sodium fluoride
Pharmaceutical form? For dental use.
A white coloured, smooth, semisolid homogenous paste.
Excipients? Glycerol (E422), Sodium benzoate (E211), Sorbitol solution (E420) (70%) (non-crystallising), Precipitated silica, Macrogol 600, Sodium lauryl sulphate, Carmellose sodium, Mint flavour (propylene glycol), Titanium dioxide (E171), Sodium saccharin (E954), Purified water
Shelf life? 24 months.
In use shelf-life: 6 months.
Storage Do not store above 25°C.
Drug group (ATC)? Caries prophylactic agents
  1. A Alimentary tract and metabolism drugs
    1. A01 Stomatological preparations
      1. A01A Stomatological preparations
        1. A01AA Caries prophylactic agents
          1. A01AA01 sodium fluoride
Marketing authorisation? PL 30684/0271 (first authorised 27 January 2021)
Marketing authorisation holder? Dawa Limited

Sources: the MHRA product information (products.mhra.gov.uk). Contains public sector information licensed under the Open Government Licence v3.0.