Sold in: United States
Ingredients: fumaric acid, hydrated silica, mica, peg-12, polonamer 338, sodium benzoate, sodium carbo ethylcellulose, sodium lauryl sulfate, sodium saccharin, clinical pharmacology: frequent topical applications to the teeth with preparations having a relatively huoride content increase tooth resistance to acid sorbitol, titanium dioxide, tricalcium phosphate, water, xant an gum, this product also contains flavor fd,c blue no oearmint only), fd,c red no, 33 (fruitastic only dissolution and enhance penetration of the fluoride ion irto tooth enae indications and usage: a dental caries preventive, for once daily self-applied topical use, it is well establis that 1,1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently vith mouthpiece applica prevident 5000 boostelis 1,1% sodium fluoride toothpaste in a squeeze prefe applied onto a toothbrush, this prescrint tete chold be sed once daily in place of vour paular toothpaste unless otherwise instructed by your dental professional, may be used in areas where drinking wateris fluoridated since topical fluoride cannot produce fluorosis, (see warnings for exception,) contraindications: do not use in pediatric patients under age 6 years unless recommended by a dentist or phyacian 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 6, 0 ppm, since younger pediatric patients frequently cannot pefom the brushing process ithout sionificant swallowing, use in pediatric patients use of this product, read directions carefully before using kep out of reach of infants and children, precautions: general: not for systemic treatment, do not swallow, requires special supervision to prevent repeated swallowing of toothpaste which could cause dental uorosis, pediatic patients under age 12 should be supervised in the carcinogenesis, mutagenesis, impairment of fert lity: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 4,1 to 9,1 mgkg of body weight, equivocal evidence of carcinogenesis was reported in male rats treated with 25 and 4,1 mg/kg of body weight, in a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11,3 mg/kg of body weight, epidemiological data provide no credible evidence for an association between fuoride, 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 abrrations in cultured human and rodent cells at doses much higher than those to which humans are exposed, in vwo tata are comflicting, 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 ox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water other studies conducted in rats demonstrated that lower oncentrations of fluoride (5 mg/kg of body weight) did ntresut in impaired fertility and reproducctive capabilities pregnancy: teratogenic effects: pregnancy category ,, it has been shown that fluoride cresses the placenta of ruts, but only 0,01% of the amount administered is ncorporated in fetal tissue, animal studies (rats, mice, ratbit tave sshown that fluoride is not a teratogen, maternal exposure to 12,2 mg fluoride kg of body weight (rats) 13,1 mg/kg of body weight (rabbits) did not affect the itter sige or fetal weight and did not inase the frequency of skeletal or visceral malformations there are no der ate and well-controlled studies in pregnant women however, epidemiological studies condced in areas with tigh levels of naturaly fluoridated water showed no in birth defects, heavy exposure to fluoride during in utero development may result in sketal fluorosis which becomes evident in childhood, mothers: it is not known if fluoride is excreted in human milk, however, many drugs are creted in milk, nd caution should be exercised when products e: the use of prevident@ 5000 boosterplus in pediatric age grours 6 to 16 years as a canies preveendive is supported by ploneering clinical studies with 1,1s ise: of the total number of subjects in clinical tudies of 1,1% ( sodium r 1of fluoride (98-137 mg/kg of body weight), no adverse effects on parturition lactation or affipring wes uoride are administered to a nursing woman, feduced milk production was reported in acaised fox vhen the animals were fed a diet containing a hih seen in rats administered fluoride up to 5 mgkg of de gels in mouth trays in students age 11 t0 14 years conducted by englander et al4 safety and effectiveness in pediatric patients below the age of 6 years wereas and over whie 1 percent were 75 and over n established, please refer to the contraindications and warnings sections
Additives: E171 - Titanium dioxide,E211 - Sodium benzoate,E297 - Fumaric acid,E420 - Sorbitol,E462 - Ethyl cellulose,E487 - Sodium dodecyl sulfate,E954 - Saccharin and its salts
NOVA group: 4