Duraphat Fluoride Varnish

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium fluoride 5%{relative};  ;  

Available from:

Colgate-Palmolive Limited (NZ)

INN (International Name):

Sodium fluoride 5% w/v

Dosage:

5% w/v

Pharmaceutical form:

Oral solution

Composition:

Active: Sodium fluoride 5%{relative}     Excipient: Colophony Ethanol Mastic Raspberry flavour 73562 Saccharin Shellac White beeswax

Units in package:

Tube, aluminium, 1 x 10ml, Al tube with white plastic screw cap & sealing plug, 10 mL

Class:

General sale

Prescription type:

Prescription

Manufactured by:

Sunlit Fluo & Chemical Co Ltd

Therapeutic indications:

Latest Regulatory Activity

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, 1 x 10ml, Al tube with white plastic screw cap & sealing plug - 10 mL - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, 5 x 30ml, Al tube with white plastic screw cap & sealing plug - 150 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1978-04-13

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Duraphat DS 17122021
Page 1 of 6
1. PRODUCT NAME
Duraphat 50 mg/mL Dental Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL suspension contains 50 mg sodium fluoride (5% w/v), equivalent to
22,600 ppm
fluoride ion (22.6 mg of fluoride) in an alcoholic solution of natural
resins.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dental Suspension
Brown/yellow, opaque suspension
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Caries prevention by deep penetration with fluoride.
Desensitisation of sensitive teeth.
4.2
DOSE AND METHOD OF ADMINISTRATION
Duraphat 50 mg/mL Dental Suspension is to be applied by the dental
professional and not
for self medication by the patient. For best results, remove excess
plaque and dry teeth
before applying Duraphat. Duraphat is applied as a thin layer to the
most susceptible areas
of dentition using a brush, probe or applicator. Refer to Section 6.6
for further pre-application
recommendations.
RECOMMENDED DOSAGE FOR SINGLE APPLICATION:
For primary teeth: up to 0.25 mL (= 5.65 mg fluoride)
For mixed dentition: up to 0.40 mL (= 9.04 mg fluoride)
For permanent dentition: up to 0.75 mL (= 16.95 mg fluoride)
For caries prevention: the application is usually repeated every 6
months but more frequent
applications (every 3 months) may be made.
For hypersensitivity: 2 or 3 applications should be made within a few
days.
The patient should not brush the teeth or chew food for 4 hours after
treatment.
Method of administration: For dental use.
NEW ZEALAND DATA SHEET
Duraphat DS 17122021
Page 2 of 6
4.3
CONTRAINDICATIONS
Hypersensitivity to any ingredients of Duraphat.
Ulcerative gingivitis.
Stomatitis.
Bronchial asthma.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Application of Duraphat 50 mg/mL Dental Suspension to the whole
dentition should not be
carried out on an empty stomach.
On the day when Duraphat has been applied, no high dose fluoride
preparations, such as
fluoride
gels,
should
be
used.
The
administration
of
fluoride
suppleme