Consumer medicine information

NeutraFluor 5000 Plus Toothpaste

Sodium fluoride

BRAND INFORMATION

Brand name

NeutraFluor 5000 Plus Toothpaste

Active ingredient

Sodium fluoride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using NeutraFluor 5000 Plus Toothpaste.

What type of product is NeutraFluor 5000 Plus

NeutraFluor 5000 Plus is a high concentration sodium fluoride toothpaste for use by patients who have a high risk of dental decay (caries).

Scientific research concludes that when toothpaste containing a relatively high amount of fluoride is applied to the teeth it offers increased protection against acid attack from decay causing bacteria in the mouth.

What is in the product

This toothpaste contains fluoride, and each treatment dose, ie a thin ribbon of paste on a toothbrush contains 2.5mg fluoride ( 5,000ppm sodium fluoride). The toothpaste also contains a number of other ingredients. These are necessary to facilitate the consistency, flavour, foaming and cleaning actions of the toothpaste. These ingredients include silica, sorbitol, saccharin, polyethylene glycol, gum, flavour, sodium benzoate, sodium laurel sulphate, titanium dioxide, sodium hydroxide and brilliant blue colour.

NeutraFluor 5000 Plus is registered on the Australian Register of Therapeutic Goods and its number is Aust R 67437. NeutraFluor 5000 Plus comes in a 56g tube.

Before using this product

NeutraFluor 5000 Plus should only be used on the recommendation of your dentist or doctor, as part of a tooth decay prevention routine.

NeutraFluor 5000 Plus should not be used by any person with known allergic reactions to fluoride or the other ingredients stated above.

Children under 6 years should not use NeutraFluor 5000 Plus unless recommended by a dentist or doctor.

Pregnant or breastfeeding women should be cautious before using this product and discuss its use with their dentist or doctor.

How to use the product properly

Do not swallow the toothpaste.

The toothpaste acts on the surface of your teeth and does not need to be swallowed.

Dosage: Follow these instructions unless otherwise instructed by your dentist or doctor:

  1. Adults and children 6 years and older:

Apply a thin ribbon of NeutraFluor 5000 Plus to a soft, small headed, multi-tufted toothbrush. Brush teeth thoroughly for two minutes.

  1. After use:

Adult spit out. Children aged 6 -16 years spit out after use and rinse mouth thoroughly. For best results, do not eat, drink or rinse your mouth for 30 minutes.

NeutraFluor 5000 Plus is easily applied on a toothbrush and should be used daily in place of regular fluoride toothpaste unless otherwise instructed by your dentist or doctor.

In the event of an overdose, contact your nearest Poisons Information Centre (or hospital accident and emergency department), or tell your doctor immediately.

Unwanted effects

Allergic reactions have been rarely reported with the use of fluoride toothpastes.

Should you experience any unwanted effect from using the product you should stop using the product and consult your doctor or dentist.

How to store the product

You should keep your NeutraFluor 5000 Plus below 25°C and out of reach of children.

This product should not be used after the expiry date which is clearly marked at the crimp on the end of the tube.

Important reminders

This toothpaste has been recommended specifically for you. Do not share this toothpaste with any one else.

If you have any concerns or questions you should not hesitate to discuss these with your dentist or doctor.

Where this product comes from

NeutraFluor 5000 Plus is a product developed by Colgate-Palmolive.
Colgate Oral Care
345 George Street
Sydney NSW 2000

For all enquiries regarding this product, please call Consumer Information Service (Free Call) 1800 802 307(Australia) or 0800 441 740 (New Zealand)

This package leaflet was developed in January 1999.

BRAND INFORMATION

Brand name

NeutraFluor 5000 Plus Toothpaste

Active ingredient

Sodium fluoride

Schedule

S3

 

Name of the medicine

Sodium fluoride.

Excipients

Purified water, sorbitol, silicon dioxide, macrogol 600, potassium pyrophosphate, xanthan gum, flavour, sodium benzoate, sodium lauryl sulphate, sodium saccharin, brilliant blue FCF 42090.

Description

Toothpaste containing neutral sodium fluoride 1.1 % w/w plus a mild cleaning system. To be used as part of a preventive regimen recommended by a dental professional or doctor. Each treatment dose, i.e. a thin ribbon of paste on a toothbrush, contains approximately 2.5 mg of fluoride (≡ sodium fluoride 5000 ppm).

Pharmacology

Clinical pharmacology.

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Indications

In individuals at high risk for caries, the use of a high concentration fluoride toothpaste as part of a preventive regimen prescribed by a dental professional is a rational approach to caries control. Sodium fluoride 1.1% was first reported to provide significant protection against dental caries in the 1960s when it was applied in a mouth tray daily to school children1-2. NeutraFluor 5000 Plus is easily applied on a toothbrush and should be used daily in place of regular fluoride toothpaste unless otherwise instructed by a dental professional. More recent studies have shown its effectiveness in preventing dental caries in children with high caries experience, adults with root caries and patients with xerostomia3-5. As NeutraFluor 5000 Plus delivers fluoride topically to teeth and is intended for erupted teeth in adults and children over the age of ten, the increased fluoride dose should not contribute to fluorosis provided it is not used in an unsupervised manner in children under ten years of age.

Contraindications

Known hypersensitivity to any of the stated ingredients.

Precautions

Not for systemic use. Do not swallow. Not for use in children under 10 years unless recommended by a dentist or physician. If recommended for use in children under 10 years, parental supervision of brushing should be recommended. Prolonged daily ingestion may result in various degrees of dental fluorosis in children under 10 years, especially if the water fluoridation exceeds 0.6 ppm, since younger children frequently cannot perform the brushing process without significant swallowing.

Use in pregnancy.

(Category B1)
It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administrated is incorporated in foetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Fluoride has been taken by a limited number of pregnant women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effect on the human foetus having been observed. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Use in lactation.

It is not known if fluoride is excreted in breast milk. However many drugs are excreted in milk and caution should be exercised when products containing fluoride are administered to lactating women.

Interactions

There are no expected drug interactions with topically applied fluoride.

Adverse Effects

Allergic reactions and other idiosyncrasies have been rarely reported.

Directions For Use

Adults, children 10 years and older.

A thin ribbon of NeutraFluor 5000 Plus should be applied to a soft toothbrush. Teeth should be brushed thoroughly for two minutes.
After use, spit out excess toothpaste and refrain from eating, drinking or rinsing for 30 minutes.

Overdosage

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting and diarrhoea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, haematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg bodyweight has been ingested give calcium (e.g. milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg/bodyweight has been ingested give orally soluble calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution) and seek immediate medical assistance. For accidental ingestion of more than 15 mg fluoride/kg/bodyweight, admit immediately to a hospital facility.

Presentation

Toothpaste, 1.1% w/w (fluoride 280 mg): 56 g tube.

Storage

Store below 25°C.

References

1. Englander HR, Keyes et al JADA 75: 638-644, 1967
2. Englander HR, et al; JADA 83: 354-358, 1971
3. Dreizen S et al; J Den Res 56: 99-104, 1977
4. Cutress T et al; J Dent Child 59: 313-8, 1992
5. De Paola P; In Cariology for the 90's: 26-35p
6. ARCPOH; Aust. Dent. J 2006; 51(2): 195-199

Poison Schedule

S3.