Clinpro™ 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste is made by 3M. On 3M’s website for this toothpaste it states “Prescription only” and “For use as part of a professional program for the prevention and control of dental caries.” Medline Plus also lists it as a prescription drug.
Posted on Denver’s Craiglist today:
“This is For Clinpro 2000 1.1% Sodium Fluoride Toothpaste brand new in a 4oz tube. Expiration 03/2017 There is five tubes for sale and each one is $19 or $75 for all. Thanks!”
Also selling it online is Dental Health Essentials. They charge $29.99 for a 4 oz. tube. Their website states the toothpaste is “available in vanilla mint and bubble gum flavors.”
Page 3: Demineralization is first visible as a “white spot lesion” on the surface of the tooth enamel. Left untreated, this process can continue, eventually leading to cavitation.
Page 6: “White spot lesions” are an early sign of tooth decay that, if left untreated, will progress to frank caries lesions.
Page 11: contains 5000 ppm fluoride ion, 4 times more fluoride than regular adult toothpaste
Page 14: USE IN SPECIFIC POPULATIONS
Fluoride crosses the placenta in women and has been measured in cord blood, amniotic fluid, and serum of newborn children, but without a consistent correlation to maternal serum fluoride levels [1,2]. There are no data to indicate an increased susceptibility to fluorosis during pregnancy. Developmental studies were conduced by the National Toxicology Program, with sodium fluoride administered in the drinking water to pregnant rats and rabbits. No developmental toxicity was observed, even at doses that caused maternal toxicity. The No Adverse Effect Levels were about 29mg/kg-day and 27mg/kg-day for rabbits and rats, respectively . There is no conclusive evidence of fluoride developmental effects in humans [1,2]. The Institute of Medicine established a fluoride Upper Limit of 10mg/day for pregnant women .
Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water and other sources) when prescribing the product for use in pregnant women or women who may become pregnant.
8.3 Nursing Mothers
An extremely small proportion of fluoride in drinking water is transferred to breast milk. The Institute of Medicine established a fluoride Upper Limit of 10mg/day for nursing women . Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water and other sources) when prescribing the product for use in pregnant women or women when prescribing the product for use in women who are nursing.
8.4 Pediatric Use
The primary adverse effects of fluoride are fluorosis of dental enamel and of the skeleton; these effects occur at exposures below those associated with other adverse health effects. The population most at risk for dental fluorosis is children during the period of tooth formation, i.e. from birth to 8 years of age. For this population, the Institute of Medicine (IOM) established Fluoride Upper Limits of intake based on the risk of dental fluorosis. In populations with permanent dentition, skeletal fluorosis is the greatest risk from excessive fluoride. For this population the Institute of Medicine established Fluoride Upper Limits based on the risk of skeletal fluorosis .
8.5 Geriatric Use
No studies of Clinpro 5000 Anti-Cavity Toothpaste have been conducted to determine whether subjects aged 65 and over respond differently from younger subjects.
1. National Research Council. Fluoride in drinking water. A scientific review of EPA’s standards; National Academies Press 2006.
2. IOM. Dietary Reference Intakes: The essential guide to nutrient requirements. National Academies Press 2006.
3. Heindel JJ, et al. Developmental toxicity evaluation of sodium fluoride administered to rats and rabbits in drinking water. Fundam Appl Toxicol 1996;30(2):162-177.
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NOTE from FAN:
Excerpts from the Heindel (NIEHS) et al. study cited above, on the Embryo–fetal effects on rats:
… Although there were no significant pairwise effects from sodium fluoride administration, the percentage of litters with one or more external malformed fetuses, the percentage of externally malformed fetuses per litter and the percentage of skeletally malformed fetuses per liter, exhibited increasing trends with increasing dose of sodium fluoride (Table 2 and 3). No significant effect were noted in the prevalence of variations in the examined fetuses (Table 3).
… Examination of individual fetal findings indicated that no fetuses with external malformations were observed in the control or low-dose groups. The external malformations observed in the mid- and high-dose groups are given as follows and 0ther types of malformations in the same fetus are shown in brackets:
(1) at 150 ppm, one male fetus (1/362 fetuses examined) exhibited gastroschisis (and cleft sternum], the fetus weighed 3.0 g; (2) at 300 ppm, three fetuses (3/373 fetuses examined) exhibited multiple malformations as follows: one male fetus (3.1 g) exhibited anasarca [and displaced and small kidney, displaced testis, and bipartite thoracic centrum], one male fetus (1.7 g) displayed craniorachischisis and micropthalmia [as well as fused ribs and bipartite thoracic centrum]; and one female fetus (1.3 g) exhibited bilateral anophthalmia, cranioraschischisis, gastroschisis, and ectocardia [as well as renal agenesis, right side]. At 300 ppm, two of the three fetuses with malformations were clustered in one litter. All of the external malformations, as well as the associated visceral and skeletal malformations, occur spontaneously in this species and strain with a low incidence (Charles River, 1993), with the possible exception of ectocardia. The one rat fetus with ectocardia (externalization of the heart or thorachoschisis) in this study was also reported to show gastroschisis. Thus, fissure of the ventral wall was quite extensive, and ectocardia was not an isolated defect. Considering the low incidence of these external malformations, and the lack of a statistically significant difference among groups, there was insufficient evidence to establish a clear cause and effect relationship between the occurrence of these external malformations and sodium fluoride exposures.
In light of these considerations, as well as the absence of any effect on fetal growth or viability, there was insufficient evidence to clearly characterize the group at 300 ppm as an adverse effect level for developmental toxicity in the rat. Higher concentrations of sodium fluoride in drinking water were not evaluated in the rat study due to reported toxicity in adult rats >300 ppm in drinking water (NTP, 1990). Thus, it was not feasible to determine whether the finding of uncommon malformations in a small number of rodent fetuses at the high dose might constitute the lower tail of a dose-response curve. As noted above, administration of higher concentrations of sodium fluoride throughout gestation is not feasible due to the unpalatability of the solution.
… Fluoride crosses the placenta of humans and animals, including rats and rabbits (Ericsson and Malmnas, 1962; Zipkin and Babeaux, 1965). Thus, maternal supplementation during pregnancy results in increased fluoride concentrations not only in maternal blood, but also in cord blood and offspring tissues, especially bones and teeth (Theuer et al., 1971; Katz and Stookey, 1973; Drinkard et al., 1985; Speirs, 1986; Caldera et al., 1988; Gedalia and Shapira, 1989; Chan et al., 1989).