COLGATE TOTAL PRO GUM HEALTH TOOTHPASTE

Active substance: TRICLOSAN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Colgate TOTAL Pro Gum Health Toothpaste

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients of Colgate TOTAL Pro Gum Health Toothpaste are:
Triclosan

0.30% w/w

Sodium Fluoride

0.32% w/w 1450 ppm F

For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Toothpaste.
White toothpaste with odour and flavour of mint.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
To reduce dental caries.
To improve gingival health by:1. Significantly reducing the formation of plaque and calculus.
2. 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

Contraindications

None known.
Individuals with known sensitivities should consult with their dentist before using.
4.4

Special warnings and precautions for use
Children under 7, use a pea-sized amount for supervised brushing. If using
fluoride supplements, consult your Dentist.
May cause skin irritation

4.5

Interaction with other medicinal products and other forms of interaction
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

Pregnancy and lactation
Use of this product is not contraindicated during pregnancy or lactation.

4.7

Effects on ability to drive and use machines

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
Triclosan: 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™ Pro Gum Health Toothpaste it is combined with a copolymer
which enhances the delivery of Triclosan to the site of action.
Clinical studies indicate that a single brushing with the triclosan/copolymer dentifrice
significantly reduces dental plaque viability (the ratio of live to dead bacteria in
dental plaque) compared to a control dentifrice without the anti-bacterial system. A
significant difference is maintained for at least 12 hours after brushing. The results
also indicate that the concentrations of triclosan in dental plaque for at least 12 hours
after brushing are at levels known to have anti-bacterial effects in vitro.
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 Pro Gum Health 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
Silica, Dental Type
Sorbitol, Liquid (70%) Non-Crystallising
Purified Water
Poly (Methyl Vinyl Ether) Maleic Acid
Sodium Hydroxide (25% Solution)
Sodium Laurilsulfate
Mint Flavour (contains Propylene Glycol)
Carmellose Sodium
Titanium Dioxide (E171)
Iota Carrageenan
Saccharin sodium

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 Pro Gum Health Toothpaste is packaged in 19, 50, 75, 100, 125, and
150 ml lay down foil laminate tubes and 100, 125 and 150 ml stand-up-tubes
consisting of three elements: a) conical shoulder with threaded neck manufactured
from high density polyethylene, b) barrier material of polybutyl teraphthalate (PBT)
or polyester teraphthalate (PET) below and inside the conical shoulder, c) cylindrical
laminated tube body.
The lay down tube body is manufactured from 5-ply laminated webstock comprising
from outside to inside:
Outer layer:

Polyethylene
Adhesion copolymer
Aluminium foil
Adhesion copolymer

Inner layer:

Polyethylene

The stand-up-tube body is manufactured from polyethylene laminate comprising:
Medium density polyethylene
Ethylvinyl alcohol barrier
Medium density polyethylene.
The caps are manufactured from polypropylene and are either screw or snap-on.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER

Colgate-Palmolive (U.K.) Ltd
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL00049/0036

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

Date of first authorisation: 25 October 1995
Date of last renewal: 25 October 2000

10

DATE OF REVISION OF THE TEXT
12/07/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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