Colgate Total® is the first and only toothpaste to be approved by the FDA and accepted by the ADA for most major adult preventive concerns. Colgate Total® has been clinically proven effective against caries, gingivitis, plaque and calculus. The formulation also provides long-lasting fresh breath. In fact, many dental experts consider it the most significant advancement in oral care since the introduction of fluoride. We believe that Colgate Total®, with its technology and benefits, will redefine oral health.
A New Drug Application (NDA) for Colgate Total® was submitted to the United States Food and Drug Administration (FDA). This was necessary because of a new ingredient in the product, the product claims, and the benefits the product provides. This review has successfully concluded with FDA approval of Colgate Total® toothpaste, which means that the FDA has determined that the product is safe and effective for its intended use. It is rare for an NDA for a new toothpaste to be cleared by the FDA. This is the first toothpaste that has received NDA approval in over 10 years! FDA clearance was granted on July 11, 1997.
The unique formula of Colgate Total®, containing fluoride and the antibacterial ingredient triclosan, is the only toothpaste approved by the FDA with clinically proven ingredients that help prevent gingivitis, plaque, and cavities, as well as tartar and bad breath. And, because it also contains a unique copolymer, PVM/MA, it continues to be active between brushings for up to 12 hours.
Colgate Total® provides therapeutic benefits against caries, gingivitis, and plaque. In addition, it's effective in reducing supragingival calculus and providing long-lasting breath protection. You can recommend Colgate Total® with confidence to all your patients over 6.
Colgate Total® is the only toothpaste to contain triclosan with a copolymer. Triclosan is an effective antibacterial ingredient that controls a wide range of bacteria. The copolymer is used in the formulation to prolong retention of triclosan on oral hard and soft tissues and in plaque. Without the copolymer, triclosan would be rapidly lost from the mouth, reducing its clinical effect.
Yes. Numerous safety studies that support its safety have been carried out by Ciba-Geigy (the manufacturer of triclosan), Colgate, and leading academics. Also, before permitting it to be marketed in the US, the FDA conducted an extensive review of data in Colgate's clinical tests. These included five major studies that supported the safety and efficacy of the toothpaste. Colgate Total® was first introduced internationally in 1992 and is now sold in 173 countries worldwide. Independent dental associations in over 30 countries, including the American, Canadian and British Dental Associations, have granted seals of acceptance to Colgate Total®.
Colgate Total®'s carton is made from recycled material. The toothpaste itself has been extensively tested, and the product is environmentally safe.
Colgate Total® has a 2-year expiration date, the same shelf-life as other Colgate toothpastes. The .75 oz sample tubes of Colgate Total® have a shelf life of 18 months.
Colgate Total® is formulated with 0.24% sodium fluoride for anticaries efficacy. This translates to 1,100 ppm (parts per million) of fluoride, the same as in any Colgate Toothpaste.
Colgate Total® is indicated as an everyday toothpaste. There is no contraindication against prolonged use. Colgate Total® should be used as directed for adults and children older than 6 years of age.
Consult your doctor or physician.
Children under 6 years should not use Colgate Total® unless directed by a dentist or physician. The label for Colgate Total® states that the antigingivitis and antiplaque effects have not been proven in children.
All Colgate Total® variants are below the FDA- and ADA-recommended maximum of 250.
* vs non-antibacterial fluoride toothpaste.
† Defined as fluoride for cavity protection plus 12-hour antibacterial protection against gingivitis.
‡Greater reduction of cultivable anaerobic bacteria in saliva and on tongue, teeth, and cheeks compared to non-antibacterial fluoride toothpaste.
§ Colgate Total® is approved through the New Drug Application process to help prevent plaque, gingivitis, and caries. Not approved for the prevention or treatment of serious gum disease or other diseases.
References1. Amornchat C, Kraivaphan P, Triratana T. Mahidol Dent J. 2004:24:103-111. 2. Lindhe J, Rosling B, Socransky SS, et al. J Clin Periodontol. 1993;20:327-334.