Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Geriatric Use: Of the total number of subjects in clinical studies of 1. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion within 30 minutes and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.
These symptoms may persist for 24 hours. Please Call www. How to Order. Contact Us. United States US English. Colgate Professional Direct. Shop Colgate Professional. Brand Logo. All rights reserved. Terms Of Use. Privacy Policy. About Our Ads. Children's Privacy Policy. California Compliance. Colorado Prescribers. Terms of sale. I am a dental professional. I am not a dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.
Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste, which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.
General: Not for systemic treatment. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4. Equivocal evidence of carcinogenesis was reported in male rats treated with 2. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed.
In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.
Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to ppm or greater concentrations of fluoride in their diet or drinking water. It has been shown that fluoride crosses the placenta of rats, but only 0.
Animal studies rats, mice, rabbits have shown that fluoride is not a teratogen. Maternal exposure to There are no adequate and well-controlled studies in pregnant women.
However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood. Nursing Mothers: It is not known if fluoride is excreted in human milk. Indications and Usage A dental caries preventive; for once-daily self-applied topical use.
Indications and Usage A dental caries preventive; for once daily self-applied topical use. Contraindications Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Warnings Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.
Precautions General: Not for systemic treatment. Overdosage Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Brush thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages years, expectorate after use and rinse mouth thoroughly.
How Supplied 3. Joziak MT et al. J Dent Res. Abstract Baysan A et al. Caries Res. Jensen J et al. Ann NY Acad Sci. Data on file. Englander HR et al. Colgate Oral Pharmaceuticals. Product Description Soothing Mint 3. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. General: Not for systemic treatment. Allergic reactions and other idiosyncrasies have been rarely reported.
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