Neutrafluor 5000 Plus

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium fluoride 1.105%{relative} equivalent to 5000 ppm fluoride ion;  ;  

Available from:

Colgate-Palmolive Limited (NZ)

INN (International Name):

Sodium fluoride 1.105% w/w (equivalent to 5000 ppm fluoride ion)

Dosage:

1.1% w/w

Pharmaceutical form:

Toothpaste

Composition:

Active: Sodium fluoride 1.105%{relative} equivalent to 5000 ppm fluoride ion     Excipient: Brilliant blue FCF Dental cream flavour B089054 Hydrated silica as Zeodent 165 3%w/w + Zeodent 115 17.605%w/w Macrogol 600 Potassium pyrophosphate Purified water Saccharin sodium Sodium benzoate Sodium laurilsulfate Sorbitol Xanthan gum

Units in package:

Tube, plastic, 56g, 56 g

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Sunlit Fluo & Chemical Co Ltd

Therapeutic indications:

Dental caries prevention for individuals at high risk for caries, when used as part of a preventative regimen recommended by a dental professional or doctor.

Product summary:

Package - Contents - Shelf Life: Tube, plastic, 56g - 56 g - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1999-08-25

Summary of Product characteristics

NeutraFluor Plus DS 110219.1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
NeutraFluor 5000 Plus
5000ppm Fluoride Professional Toothpaste
1.1% w/w Neutral Sodium Fluoride plus a mild cleaning system
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
ACTIVE INGREDIENT: sodium fluoride 1.1% (w/w)
EXCIPIENTS: Purified water, sorbitol, silicon dioxide, macrogol 600,
potassium pyrophosphate,
xanthan gum, flavour, sodium benzoate, sodium lauryl sulphate, sodium
saccharin, brilliant blue
FCF 42090.
3.
PHARMACEUTICAL FORM
Toothpaste
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
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
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 xerostomia
3-6
. 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 increades
fluoride dose should not contribute to fluorosis provided it is not
used in an unsupervised manner
in children under ten years of age.
NeutraFluor Plus DS 110219.1
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 Res56: 99-104, 1977
4.
Cutress T et al; J Dent Child 59: