Active Ingredient: Sodium Fluoride 1.1% w/w CAS number: 7681-49-4
NeutraFluor 5000 Gel is a self-applied topical 1.1% w/w neutral sodium fluoride toothpaste for use as a dental caries preventive in individuals at high risk for caries. To be used as part of a preventive regimen recommended by a dental professional or doctor. Excipients: Water, Sorbitol, Silicon Dioxide, Macrogol 600, Sodium phosphate, Sodium lauryl sulphate, Flavour, Xanthan gum, Tetra potassium pyrophosphate, Sodium benzoate, Saccharin sodium, Mica, Sodium hydroxide, Titanium dioxide, Brilliant blue FCF.
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. 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. 1.1% sodium fluoride was first reported to provide significant protection against dental caries in the 1960's when it was applied in a mouth tray daily to school children 1-2. Neutrafluor 5000 Gel 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 xerostomia 3-6. Neutrafluor 5000 Gel delivers fluoride topically to teeth and is intended for erupted teeth in adults and children over the age of twelve.
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Cutress T et al; J Dent Child 59: 313-8, 1992
De Paola P; In Cariology for the 90's: 26-35p 6. ARCPOH; Aust.Dent. J 2006; 51(2):195-199
Dental caries preventative for individuals at high risk for caries, when used as part of a preventative regimen recommended by a dental professional or doctor.
Known allergic reactions or hypersensitivity to any of the stated ingredients.
Not for systemic treatment. DO NOT SWALLOW. Not for use in children under 12 years unless recommended by a dentist or physician. If recommended for use in children under 12 years, parental supervision of brushing should be recommended. Prolonged daily ingestion may result in various degrees of dental fluorosis in children under 6 years; especially if the water fluoridation exceeds 0.6ppm, since younger children frequently cannot perform the brushing process without significant swallowing.
Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered 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.
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.
There are no expected drug interactions with topically applied fluoride.
Allergic reactions and other idiosyncrasies have been rarely reported.
Adults and children 12 years and older: a thin ribbon of NeutraFluor 5000 Gel should be applied to a soft toothbrush. Teeth should be brushed thoroughly for two minutes.
After use, spit out excess toothpaste. Refrain from eating, drinking or rinsing for 30 minutes.
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 body weight has been ingested give calcium (eg milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight has been ingested give orally soluble calcium (eg milk. 5% calcium gluconate or calcium lactate solution) and seek immediate medical assistance. For accidental ingestion of more than 15mg fluoride /kg body weight, admit immediately to a hospital facility. Contact the New Zealand Poisons Information Centre on 0800 POISON for specific treatment and recommendations. A treatment dose (a thin ribbon) of NeutraFluor 5000 Gel contains approximately 2.5mg Fluoride
The paste contains 1.1% w/w neutral sodium fluoride. It is a blue sparkled paste in a 122g bottle. Store below 25oC.
Colgate-Palmolive Limited (NZ) PO Box 38077 PETONE 5045
Restricted Medicine
Approved by Medsafe 04 October 2012 Amendment: n/a