Clinpro 5000

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Sodium fluoride 1.12%;  
Available from:
3M New Zealand Ltd
INN (International Name):
Sodium fluoride 1.12%
Dosage:
1.12 %
Pharmaceutical form:
Toothpaste
Composition:
Active: Sodium fluoride 1.12%   Excipient: Carmellose sodium Glycerol Hydrated silica as 13.92% Sident 9 + 6.5% Zeodent 165 Macrogol 600 Poloxamer 407 Purified water Saccharin sodium Sodium laurilsulfate Sorbitol TCP-SLS Titanium dioxide Vanilla mint flavour 661144
Prescription type:
Restricted
Manufactured by:
Sunlit Fluo & Chemical Co Ltd
Therapeutic indications:
Fluoride toothpaste for use after recommendation by a dental or medical professional, in the prevention of dental caries in high risk patients.
Product summary:
Package - Contents - Shelf Life: Tube, Aluminium barrier laminate tube with a HDPE tube head - 113 g - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-9251
Authorization date:
2013-03-22

Read the complete document

NEW ZEALAND DATA SHEET

Clinpro 5000 DSv2 31Aug2018

Page 1 of 6

1 PRODUCT NAME

Clinpro 5000 anti-cavity toothpaste Vanilla Mint

Clinpro 5000 anti-cavity toothpaste Spearmint

Clinpro 5000 anti-cavity toothpaste Bubble Gum

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Thick white paste containing sodium fluoride (5000 ppm F ion) 1.1% w/w (0.63% w/v fluoride

ion).

Each gram contains 5 mg of fluoride ion in a neutral pH base consisting of purified water,

sorbitol solution 70% non-crystallising, silicon dioxide, glycerol, poloxamer, flavour (Vanilla

Mint, Spearmint or Bubble Gum), macrogol 600, sodium lauryl sulfate, titanium dioxide,

carmellose sodium, saccharin sodium and TCP-SLS (modified calcium phosphate).

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Clinpro 5000 is a self-applied fluoride dentifrice presented as a thick white paste for the

prevention of dental caries.

4 CLINICAL PARTICULARS

4.1

Therapeutic indications

Clinpro 5000 is a fluoride toothpaste for use after recommendation by a dental or medical

professional, in the prevention of dental caries in high risk patients.

4.2

Dose and method of administration

Clinpro 5000 is recommended for adults and children 6 years of age and older, as part of a

caries prevention program.

Use Clinpro 5000 once daily in place of a conventional toothpaste unless instructed

otherwise by a dentist or physician.

Apply a thin ribbon or pea-sized amount of Clinpro 5000 to a soft-bristled toothbrush and

brush teeth for at least two minutes.

After brushing, adults should expectorate. Children 6 to 16 years of age should expectorate

and rinse mouth thoroughly with water.

For best results, do not eat or drink for 30 minutes after use.

Follow these instructions or use as directed by a dental professional.

4.3

Contraindications

Known allergic reactions or hypersensitivity to any of the stated ingredients.

Not recommended for use in children under 6 years of age.

NEW ZEALAND DATA SHEET

Clinpro 5000 DSv2 31Aug2018

Page 2 of 6

4.4

Special warnings and precautions for use

Clinpro 5000 must not be swallowed. If more than a pea-sized amount of Clinpro 5000 is

swallowed, contact a Poison Information Centre (in Australia 131 126 and in New Zealand

0800 764 766).

Repeated ingestion of high levels of fluoride may cause dental fluorosis. For this reason, use

in children with developing dentition requires special supervision to prevent swallowing. The

risk of fluorosis should be considered if prescribing for use in children less than 6 years of

age.

Use in the Elderly

No studies have been conducted to determine whether subjects aged 65 and over respond

differently from younger subjects.

Paediatric Use

The primary adverse effects of fluoride are fluorosis of dental enamel and of the skeleton;

these effects occur at exposures below those associated with other adverse health effects.

The population most at risk for dental fluorosis is children during the period of tooth

formation, i.e. from birth to 8 years of age. For this population, the NHMRC established

Fluoride Upper Limits of intake based on the risk of dental fluorosis. In populations with

permanent dentition, skeletal fluorosis is the greatest risk from excessive fluoride. For this

population the NHMRC established Fluoride Upper Limits based on the risk of skeletal

fluorosis.

Population

NHMRC Fluoride Upper Limit

Infants 0-6 months old

1.2mg/day

Infants 7-12 months old

1.8mg/day

Children 1-3 years old

2.4mg/day

Children 4-8 years old

4.4mg/day

Children > 8 years old

10 mg/day

The NHMRC Fluoride Upper Limit levels for 0-8 year olds were updated in 2017. The

following reference body weights were used when the 2017 Nutrient Reference Values for

infants and young children aged 0-8 years were expressed in mg fluoride/day; 0-6 months

6kg, 7-12 months 9kg, 1-3 years 12kg, 4-8 years 22 kg.

Repeated ingestion of high levels of fluoride may cause dental fluorosis. For this reason, use

in children with developing dentition requires special supervision to prevent swallowing.

Clinpro 5000 is not recommended for use in children under 6 years of age.

Prescribing dentists and physicians should consider total fluoride exposure (dental care plus

food, water and other sources) when prescribing the product for use in children.

4.5

Interaction with other medicines and other forms of interaction

There are no expected medicine interactions with topically applied fluoride.

4.6

Fertility, pregnancy and lactation

Use in Fertility

NEW ZEALAND DATA SHEET

Clinpro 5000 DSv2 31Aug2018

Page 3 of 6

No data available.

Use in Pregnancy

Fluoride crosses the placenta in women and has been measured in cord blood, amniotic

fluid, and serum of newborn children, but without a consistent correlation to maternal serum

fluoride levels. There are no data to indicate an increased susceptibility to fluorosis during

pregnancy. Developmental studies were conducted by the US National Toxicology Program,

with sodium fluoride administered in the drinking water to pregnant rats and rabbits. No

developmental toxicity was observed, even at doses that caused maternal toxicity. The No

Adverse Effect Levels were about 29 mg/kg-day and 27 mg/kg-day for rabbits and rats,

respectively. There is no conclusive evidence of fluoride developmental effects in humans.

The Australian National Health and Medical Research Council (NHMRC) have established a

Fluoride Upper Limit of 10 mg/day for pregnant women.

Prescribing physicians and dentists should consider total fluoride exposure (dental care plus

food, water and other sources) when prescribing the product for use in pregnant women or

women who may become pregnant.

Use in Lactation

An extremely small proportion of fluoride in drinking water is transferred to breast milk. The

NHMRC has established a Fluoride Upper Limit of 10 mg/day for nursing women.

Prescribing physicians and dentists should consider total fluoride exposure (dental care plus

food, water and other sources) when prescribing the product for use in women who are

nursing.

4.7

Effects on ability to drive and use machines

The effects of this medicine on a person’s ability to drive and use machines were not

assessed as part of its registration.

4.8

Undesirable effects

Allergic reactions and other idiosyncrasies have been rarely reported with the use of fluoride

toothpastes.

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions

https://nzphvc.otago.ac.nz/reporting/

4.9

Overdose

Ingestion of large amounts of fluoride may result in abdominal pain, stomach upset, nausea,

vomiting, and diarrhoea. These symptoms may occur at overdosages of 5 mg/kg of body

weight. Fluoride doses of 16 mg/kg have been fatal.

A thin ribbon or pea-sized amount of Clinpro 5000 weighs approximately 0.3 g and contains

approximately 1.5 mg of fluoride ion. A 113g tube contains 564 mg of fluoride ion.

Contact the Poisons Information centre (in Australia 131126 and in New Zealand 0800 764

766) for the most up-to-date treatment recommendations.

NEW ZEALAND DATA SHEET

Clinpro 5000 DSv2 31Aug2018

Page 4 of 6

5 PHARMACOLOGICAL PROPERTIES

The molecular formula of sodium fluoride is NaF.

CAS 7681-49-4

Clinical Pharmacology

The fluoride delivered to the teeth from Clinpro 5000 inhibits the demineralisation of sound

teeth and enhances the remineralisation (i.e., repair) of demineralised teeth. During tooth

brushing, fluoride is taken up by teeth and dental plaque. Fluoride is taken up with calcium

and phosphate by demineralised teeth resulting in an improved tooth structure that contains

more fluoride and less carbonate than naturally occurring tooth structure and is more

resistant to acid challenge. Additionally, calcium fluoride is formed on the crystal structure of

teeth. As the pH of the mouth drops, fluoride is released from calcium fluoride and aids in the

remineralisation of teeth. Fluoride taken up into plaque alters the activity of cariogenic

bacteria. Fluoride inhibits the process by which cariogenic bacteria metabolise

carbohydrates resulting in less acid and adhesive polysaccharide production by the bacteria.

6 PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Carmellose sodium

Glycerol

Hydrated silica

Macrogol 600

Poloxamer 407

Purified water

Saccharin sodium

Sodium lauryl sulfate

Sorbitol solution 70%

TCP-SLS

Titanium dioxide

Flavour – vanilla mint, spearmint, bubblegum

6.2

Incompatibilities

In the absence of compatibility studies, this medicine must not be mixed with other

medicines.

6.3

Shelf life

Clinpro 5000 Vanilla Mint anticavity toothpaste 113g - 36 months

Clinpro 5000 Spearmint anticavity toothpaste 113g - 36 months

Clinpro 5000 Bubblegum anticavity toothpaste 113g - 24 months

Not all flavours may be marketed.

NEW ZEALAND DATA SHEET

Clinpro 5000 DSv2 31Aug2018

Page 5 of 6

6.4

Special precautions for storage

Store below 25°C.

6.5

Nature and contents of container

Laminate tube with flip top cap containing 113g of paste.

Available in Vanilla Mint, Spearmint and Bubble Gum flavours

not all flavours may be marketed

6.6

Special precautions for disposal

Any unused medicine or waste material should be disposed of in accordance with local

requirements.

7 MEDICINE SCHEDULE

Pharmacist Only Medicine

8 SPONSOR

3M New Zealand Limited

94 Apollo Drive

Rosedale

Auckland 0632.

Telephone: 09 477 4040

9 DATE OF FIRST APPROVAL

19 December 2013

10 DATE OF REVISION OF THE TEXT

31 August 2018

NEW ZEALAND DATA SHEET

Clinpro 5000 DSv2 31Aug2018

Page 6 of 6

SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

Added excipient reference statement as per

DS template

Added ‘presented as a’ to link statements

previously from description and

presentation sections

Updated NHMRC Fluoride Upper Limits

values as per revised published guidelines

as at March 2017

Added fertility statement as per DS

template

Added statement as per DS template

Added reporting details for suspected

adverse reactions as per DS template

Added full list of excipients as per TPDR

Added incompatibility statement as per DS

template recommendation

Added shelf life as per TPDR and

marketing status statement

Added reference: ‘not all flavours may be

marketed’ as per DS template guidance

Added disposal statement as per DS

template

Added sponsor telephone number as per

DS template recommendation

Added date of first approval as per TPDR

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