1. Name Of The Medicinal Product
Colgate TOTAL™ Toothpaste
2. Qualitative And Quantitative Composition
The active ingredients of Colgate TOTAL™ Toothpaste are:
Triclosan 0.300% w/w
Sodium Fluoride EP 0.32% w/w 1450 ppm F
3. Pharmaceutical Form
This product is a dental cream for dental hygiene.
White toothpaste with odour and flavour of mint.
4.1 Therapeutic Indications
To reduce dental caries.
To improve gingival health by:
- Significantly reducing the formation of plaque and calculus.
- Significantly reducing existing levels of gingival bleeding and inflammation.
To reduce the progression of Periodontitis.
4.2 Posology and Method of Administration
For dental use.
The usual dosage is to apply a ribbon of toothpaste across the head of the toothbrush (approximately 1.0g) and to brush the teeth for one minute twice daily.
Children under 7, use a pea-sized amount for supervised brushing to minimise swallowing. If using fluoride supplements, consult your Dentist.
4.3 Contra-indications
None known.
Individuals with known sensitivities should consult with their dentist before using.
4.4 Special Warnings and Special Precautions for Use
Children under 7, use a pea-sized amount for supervised brushing. If using fluoride supplements, consult your Dentist.
4.5 Interactions with Other Medicines and Other Forms of Interactions
None known. It is important to note that as for any fluoride containing toothpaste in children under systemic fluoride therapy, it is important to evaluate the total exposure to fluoride (fluorosis).
4.6 Use in Pregnancy and Lactation
Use of this product is not contraindicated during pregnancy or lactation.
4.7 Effects on Ability to Drive or Use Machinery
None known.
4.8 Undesirable Effects
None known.
4.9 Overdose
Not applicable. Use of this type of product would not be expected to result in an overdose.
No acute effects would be expected from the low level of Triclosan (489 mg in a 125 ml tube). Even in the extreme case of prolonged exposure, serious adverse effects would not be expected from Triclosan.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC code: A01AA01
riclosan: Triclosan is a broad-spectrum non-ionic antibacterial with activity against both aerobic and anaerobic gram-positive and gram-negative microbes. It is widely employed as a disinfectant and as an anti-bacterial in external use OTC products. In Colgate TOTAL™ Toothpaste it is combined with a copolymer which enhances the delivery of Triclosan to the site of action.
Sodium Fluoride: Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting demineralisation and promoting remineralisation of the tooth surface and by inhibiting the cariogenic microbial process.
5.2 Pharmacokinetic Properties
Triclosan: When administered in a dentifrice by toothbrushing, salivary and plaque triclosan levels range between 1-6 ppm and 25 ppm respectively at 1-2 hours after using a 0.3% dentifrice. Following usage of a dentifrice containing up to 0.6% triclosan, mean blood levels range between 15 to 25 ppb.
Blood levels of triclosan in subjects brushing with a dentifrice are about 14 per cent of those in subjects who directly ingested an aqueous solution in an equivalent dose level.
Sodium Fluoride: After oral administration, Fluoride absorption is rapid and extensive with (90 - 100%) peak Fluoride plasma levels reached within 30 to 60 minutes after ingestion. Fluoride is widely distributed through the body and concentrates in the bone and teeth. About 50% of Fluoride absorbed is stored.
Excretion is primarily through the kidneys with less than 10% being excreted in the faeces and less than 1% in sweat and saliva.
5.3 Preclinical Safety Data
Triclosan: In subchronic oral ingestion studies with rats, dentifrices containing triclosan were administered for 13 weeks at levels that are conservatively up to 100 times expected human use levels. Animals received daily doses of up to 12 mg/kg of triclosan and showed no indications of treatment related effects. This dose would be equivalent to 600 mg of triclosan in 50 kg human. Ingestion of 125 ml of a toothpaste (approximately one tube) containing 0.3% triclosan would give an intake of approximately 489 mg and would not be expected to produce untoward effects.
Sodium Fluoride: The total amount of sodium Fluoride in a 125 ml tube of Colgate TOTAL™ Toothpaste is 516 mg. This is within the acceptable limits for the amount to be dispensed at one time for safety purposes. Prolonged daily ingestion of excessive Fluoride may result in varying degrees of fluorosis.
6. Pharmaceutical Particulars
6.1 List of Excipients
Glycerol
Dental Type Silicas
Sorbitol (70% Solution)
Irradiated-Pasteurised Water
Poly (Methyl Vinyl Ether) Maleic Acid
Sodium Hydroxide (25% Solution)
Sodium Laurilsulfate
Carmellose Sodium
Titanium Dioxide
Iota Carrageenan
Sodium Saccharin
89332 Mint Flavour
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
Three years.
6.4 Special Precautions for Storage
Do not store above 25°C
6.5 Nature and Contents of Container
Colgate TOTAL™ Toothpaste is packaged in 19, 50, 75, 100 and 125 ml squeeze tubes consisting of three elements, a conical shoulder with threaded neck manufactured from high density polyethylene, a barrier material of polyester (PBT) or polyester (PET) below and inside the conical shoulder, and a cylindrical laminated tube barrel. The laminated tube barrel is manufactured from 5-ply laminated webstock consisting of:
Outer layer:
Low density polyethylene
Ethylene acrylic acid copolymer
Aluminium foil
EAA copolymer
Inner layer:
Linear medium density polyethylene100, 125 and 150ml stand up tube of polyethylene laminate consisting of:
Medium density polyethylene
EMA/EvOH barrier
Medium density polyethylene.
The cap is a conventional screw-type flip top manufactured from polypropylene.
6.6 Instructions for Use and Handling
No special requirements
7. Marketing Authorisation Holder
Colgate-Palmolive (U.K.) Ltd
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
England
8. Marketing Authorization Number
PL 0049/0036
9. Date Of First Authorization/Renewal Of Authorization
Date of first authorisation: 25 October 1995
Date of last renewal: 31 October 2005
10. Date Of Revision Of The Text
October 2005
11. Legal Classification
GSL
12. Manufacturers Recommended Retail Price
£1.19 (50ml tube), £1.99 (100ml tube)
