Colgate Total Toothpaste Information (25 July 2017)

July 27, 2017 at 9:20 AM

Dear Patients,

The following information supplied by Colgate may be of interest to you:

Colgate Total is formulated with 0.3% of the antibacterial ingredient triclosan and is clinically proven to work better than other toothpastes to reduce harmful plaque bacteria, which are the cause of most common oral health problems.
Colgate Total is approved for daily use by regulatory bodies around the world. It is approved by regulatory authorities in New Zealand, Australia, Canada, Europe, and the United States.

In the U.S., Colgate Total has been approved as safe and effective by the U.S. Food and Drug Administration (FDA) via its rigorous New Drug Application (NDA) process. This is the same process used by the FDA to approve prescription medications. The NDA approval process requires a comprehensive evaluation of human safety, including a review of nonclinical studies covering a wide array of toxicological endpoints, such as carcinogenicity, reproductive and developmental toxicity, eye and skin irritation, and short term and long term toxicity. The FDA's NDA approval also requires ongoing monitoring and updating, and we regularly provide the FDA with safety updates. The US FDA, which has issued new rules for antibacterial consumer handsoap, has not changed its approval of Colgate Total.

In Europe, independent scientific committees of the European Commission have evaluated triclosan several times and concluded that triclosan use at 0.3% in toothpaste, the level found in Colgate Total, is considered safe. Accordingly, an April 2014 amendment to the EU Cosmetic Directive confirmed triclosan's use in cosmetic toothpastes up to 0.3%. In addition, the two EU medicinal authorities who have reviewed Colgate Total with triclosan, also at 0.3%, have both approved it as safe and effective medicinal toothpaste.
 
There is good information in the FDA Consumer Updates regarding;

  • What is triclosan?
  • How safe is triclosan
  • Are there benefits of triclosan and,

What is FDA doing to evaluate the Safety of Triclosan?

This notification was kindly supplied by the New Zealand Dental Association (25 July 2017).

 




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