Sodium Monofluorophosphate (0.14% w/v fluoride ion). Other Ingredients: Calcium Lactate, Calcium Pyrophosphate, Cellulose Gum, Flavor, Beta-D-Glucose, Glycerin, Hydrated Silica, Isoceteth-20, Potassium Thiocyanate, Sodium Benzoate, Sorbitol, Xylitol. Enzyme System: Glucose Oxidase, Lactoferrin, Lactoperoxidase, Lysozyme.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Biotene Dry Mouth Toothpaste. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Biotene Dry Mouth Toothpaste. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally and appropriately. Fluoride is safe when used in doses below the tolerable upper intake level (UL) of 10 mg daily of elemental fluoride (7555). ...when used topically and appropriately. Fluoride is safe when used in quantities typically found in toothpastes, mouth rinses, and professionally applied fluoride dental treatments (8950,101102,101105).
CHILDREN: LIKELY SAFE
when used orally and appropriately.
Elemental fluoride is safe when used in doses below the daily tolerable upper intake level (UL) of 0.7 mg for 0-6 months of age, 0.9 mg for 7-12 months of age, 1.3 mg for 1-3 years of age, 2.2 mg for 4-8 years of age, and 10 mg for children 8 years and older (7555). Although infants and children have consumed fluoridated water (typically containing around 0.7 mg/L of fluoride) with apparent safety for many years, some population research has raised concerns about the potential impact of fluoride exposure on neurodevelopment (103551,115601). However, other observational research has found no correlation (115501,115600). Higher quality studies are needed. There is some concern that reconstitution of infant formula with fluoridated water might result in fluoride intakes above the UL in infants under 6 months of age, which may be linked to negative cognitive effects (103529). The Canadian Dental Association recommends that when infant formulas are used as the main source of nutrition, drinking water that contains natural fluoride above recommended levels should not be used to reconstitute the formula (103545)....when used topically and appropriately. Fluoride is safe in quantities typically found in toothpastes, mouth rinses, and professionally applied fluoride dental treatments (8950,9100,94406,107648).
CHILDREN: POSSIBLY UNSAFE
when used orally in high doses, long-term.
Exposure to high doses above the UL for greater than 10 years can cause skeletal fluorosis (7555). To reduce fluoride intake, toothpaste and fluoride rinses should not be routinely swallowed. Recommend limiting the use of toothpaste to a pea-sized amount for children 6 years and younger in case of accidental swallowing (9100). When infant formulas are used as the main source of nutrition, drinking water that contains natural fluoride above recommended levels should not be used to reconstitute the formula (103545). Children living in regions with naturally elevated levels of fluoride in drinking water may be exposed to high doses of fluoride. Some observational research suggests that exposure to drinking water with fluoride levels above 2.5 mg/L is associated with higher thyroid stimulating hormone levels (114884). Other observational research suggests that exposure to drinking water with fluoride levels of over 1 mg/L may be associated with lower IQ scores, a risk that appears to increase with each additional 1 mg/L (114849). These levels generally exceed the recommended level of fluoride in artificially fluoridated drinking water (0.7-1.2 mg/L).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately.
Elemental fluoride is safe when used in doses below the tolerable upper intake level (UL) of 10 mg daily (7555). Although fluoridated water has been consumed during pregnancy with apparent safety for many years, some population research suggests that more information is needed to determine a safe level of fluoride exposure for those living in regions with fluoridated water. Some emerging population research suggests that increased urinary fluoride levels during pregnancy might be associated with negative cognitive effects in the infant (103543,103547). However, more information is needed to determine if these results are clinically significant at the population level, as well as whether these effects are due to fluoride or to confounding factors such as socioeconomic status, use of formula instead of breast-feeding, lifestyle factors present during pregnancy, other regional environmental exposures, or the choice of IQ tests used in studies (103542,103544,103546,103547,103548,103549,103550). ...when used topically and appropriately. Fluoride is safe in quantities typically found in toothpastes, mouth rinses, and professionally applied fluoride dental treatments (8950).
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally at doses above the tolerable upper intake level (UL) of 10 mg daily of elemental fluoride for prolonged periods.
Long-term exposure to high doses can cause skeletal fluorosis, but pregnancy or lactation doesn't seem to affect susceptibility to skeletal fluorosis (7555).
Below is general information about the interactions of the known ingredients contained in the product Biotene Dry Mouth Toothpaste. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Below is general information about the adverse effects of the known ingredients contained in the product Biotene Dry Mouth Toothpaste. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, fluoride seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal symptoms.
Topically: Stained teeth.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, including atopic dermatitis, exfoliative dermatitis, gastrointestinal allergic reactions, inflamed lips, respiratory allergic reactions, stomatitis, and urticaria.
Cardiovascular ...A meta-analysis shows that exposure to drinking water high in fluoride is associated with increases in both systolic and diastolic blood pressure, and possibly an increased risk of developing hypertension, when compared with exposure to drinking water with low to normal levels. High levels of fluoride were defined as 1.02-4.06 mg/L and low to normal levels were defined as 0.18-0.84 mg/L (107650).
Dental ...Fluoride can cause enamel fluorosis, a condition in which the ingestion of excessive amounts of fluoride during the development of permanent teeth may cause discoloration and pitting. This is a cosmetic effect only; tooth enamel may be stronger and more resistant to caries with enamel fluorosis (7555). Topically, use of stannous fluoride in toothpaste has caused staining of the teeth (94409).
Endocrine
...Some in vitro and observational research has raised concerns regarding the impact of increased fluoride intake on thyroid function (115603).
The available observational research, which has taken place in multiple countries with highly variable water fluoride concentrations, has yielded conflicting findings. Some of these conflicting findings may relate to the use of urinary fluoride levels to estimate fluoride exposure. These levels can be significantly altered by various factors, including individual variability in fluoride pharmacokinetics; lifestyle factors such as smoking and alcohol consumption; and intermittently elevated intake from fluoride-containing dental products or high fluoride foods. Additionally, some population research has identified a potential interaction between iodine intake and fluoride intake on thyroid function, with higher iodine intake increasing the risk for goiter (114885) and iodine deficiency increasing the risk for elevated levels of thyroid stimulating hormone (TSH) (114889).
A 2023 meta-analysis of the available observational research evaluating fluoride intake and thyroid function identified 33 studies involving 45,000 subjects, the majority of which included children between the ages of 6 to 18. Only 6 of the included studies were considered to be at low risk for bias and only about half of the studies evaluated baseline iodine status. These studies were conducted in Asia (25 studies), Europe (3 studies), Africa (3 studies), and Canada (2 studies). The fluoride levels in drinking water for the regions included in these studies ranged from 0.8 mg/L to 25.1 mg/L; the recommended level of fluoride in U.S. drinking water is 0.7 mg/L. These studies found that water fluoride levels were directly correlated to TSH levels in adults and children; however, this correlation only occurred at water fluoride levels of 2.5 mg/L or more. There were no consistent correlations between thyroid hormone levels (including T3 and T4) and water fluoride levels, or between urinary fluoride levels and any markers of thyroid function (114884).
The impact of fluoride intake on thyroid function during pregnancy is uncertain. One case-control study of 1105 pregnant adults in Canada found that each 0.5 mg/L increase in water fluoride concentration was associated with 1.65 higher odds of primary hypothyroidism during pregnancy. However, water fluoride levels were not associated with risk of subclinical hypothyroidism. Additionally, urinary fluoride levels and estimated fluoride intake were not associated with changes in TSH. It is important to note that 74% of the cases of primary hypothyroidism reported in this study were present prior to pregnancy and study enrollment, confounding any potential association between pregnancy, fluoride intake, and TSH levels (114886).
Gastrointestinal
...Orally, fluoride can cause gastrointestinal symptoms (94405).
Enteric-coated and sustained-release dosage forms of sodium phosphate and sodium monofluorophosphate may cause fewer adverse effects than plain sodium fluoride (9127,9129). Adverse effects appear to be dose related. Sodium fluoride at high daily doses of 40-65 mg can cause nausea, vomiting, and GI bleeding (15,9127).
Immunologic ...Exposure to fluoride can cause allergic reactions including urticaria, exfoliative dermatitis, atopic dermatitis, stomatitis, and gastrointestinal allergic reactions. Respiratory allergic reactions occur rarely (15,94408). A case of dermatitis around the mouth was thought to be related to the high fluoride levels in a specific toothpaste (NeutraFluor 5000 Plus) (94408). In another case report, lip inflammation occurred in reaction to the amine fluoride in a toothpaste product (94404). Lip inflammation and urticaria were also reported in reaction to a specific brand of toothpaste (Crest Pro-Health). However, it is not clear if this reaction occurred in response to the fluoride or tin component of stannous fluoride (94403).
Musculoskeletal ...Orally, sodium fluoride 40-65 mg daily can cause lower extremity pain and stress fractures (15,9127,94405). Fluoride at high doses for prolonged periods, over 10 mg daily for 10 or more years, can cause skeletal fluorosis. Skeletal fluorosis initially presents as joint stiffness and pain, followed by crippling, osteosclerosis, muscle wasting, and neurological defects due to hyper calcification of the vertebra. Crippling skeletal fluorosis is extremely rare in the US (7555).
Neurologic/CNS
...Some observational research has found that exposure to high levels of fluoride in utero or during childhood may impact neurodevelopment.
These findings are currently exploratory; further research is warranted to determine the presence or absence of a causal relationship and whether any risk is significant at the population level (103548,103549,103550). In addition, although efforts were made to take confounding factors into consideration during the conduct of these studies, more information is needed to determine whether any neurological effects may be related to other exposures during pregnancy or childhood or to other factors such as socioeconomic status, use of formula instead of breast-feeding, lifestyle factors, or the choice of IQ tests used. Also, the actual intake of fluoride is not known in most cases (94401,103542,103544,103546,103547,103548,103549,103550,115606).
Population research that has compared IQ scores between geographic regions with high natural levels of fluoride (e.g. up to 11.5 mg/L) and those with artificially fluoridated water (e.g., concentrations between 0.7-1.2 mg/L) have found that much higher fluoride levels may be associated with a reduced IQ score (94401,103544). A meta-analysis of 30 observational studies including 12,263 children from 7 countries suggests that higher early childhood or prenatal fluoride exposure levels are associated with lower IQ scores. Dose-response analysis indicated a linear decrease in IQ score as water fluoride levels exceeded 1 mg/L, with a 3-point decrement in score for each 1 mg/L increase in water fluoride concentration. However, all but 3 studies were conducted in countries with naturally fluoridated water as opposed to those with artificial water fluoridation programs, within which water fluoride concentrations are monitored and controlled. Additionally, most studies were cross-sectional and heavily confounded, with no information on actual fluoride intake. Furthermore, the relationship between fluoride exposure and IQ score was strongest in the studies determined to be at the highest risk for bias (114849). A subsequent meta-analysis, incorporating many of the same publications in its dose-response analysis, similarly identified an inverse association between IQ score and fluoride exposure when water fluoride levels exceeded 1.5 mg/L (115607).
Research on the impact of optimally fluoridated water on neurodevelopment during infancy or childhood is conflicting. A meta-analysis of eight cross-sectional and cohort studies which evaluated the impact of fluoride levels at or below 1.5 mg/L in China, India, and Iran found no association with childhood IQ scores and fluoride exposure (115604). Two cohort studies in Australia, where water fluoridation programs are common, have found no correlation between childhood fluoride exposure and neurodevelopment. One study found no difference in behavior scores at 17 years of age between children exposed to fluoridated water during the first 5 years of life and those not exposed to fluoridated water (115600). The second study, which utilized the presence of dental fluorosis as a marker for high childhood fluoride intake, found no difference in IQ score at 16-26 years of age between those with and without dental fluorosis (115501). A cohort study using the Canadian Maternal-Infant Research on Environmental Chemicals (MIREC) cohort found an association between IQ score at 4 years and fluoride exposure during infancy, but not early childhood, in males, but not females. However, measures of fluoride intake during infancy were limited by lack of data on use of formula versus breastfeeding and the type of water used to reconstitute formula (115601). Separately, one observational study in Canada found a relationship between urinary fluoride levels and diagnosis of ADHD with higher inattention scores at age 14 years, but not at age 9 years (103551). The findings of this study are limited by the use of urinary fluoride levels, which are considered a potentially unreliable marker for fluoride intake.
There is some concern that reconstitution of infant formula with fluoridated water might result in fluoride intakes above the tolerable upper intake level (UL). One observational study in Canada found that for each 0.5-gram increase in fluoride from reconstituted formula, there is an 8.8-point decrement in performance IQ, which measures non-verbal reasoning and visual-motor coordination, at 3-4 years of age. However, there was no association with global intellectual functioning or verbal reasoning (103529). The Canadian Dental Association recommends that when infant formulas are used as the main source of nutrition, drinking water that contains natural fluoride above recommended levels should not be used to reconstitute the formula (103545).
There is also some concern that levels of fluoride found in optimally fluoridated water sources might impact fetal neurodevelopment. Emerging population research suggests that increased fluoride intake during pregnancy, as measured by urinary fluoride or dietary surveys, might be associated with negative cognitive effects. One cohort study utilizing data from the Canadian MIREC cohort found that for each 1 mg/L increase in maternal urinary fluoride, there is a 3.7-point decrement in IQ in children aged 3-4 years, with a greater reduction in non-verbal abilities than verbal abilities. A sub-analysis revealed a decrement of 4.5 points in males, with no decrement in females (103543,103547). A separate MIREC cohort study identified a potential modulating interaction between iodine exposure and fluoride exposure during pregnancy, as determined via urinary levels. Specifically, low iodine-high fluoride was associated with a greater reduction in IQ score than adequate iodine-high fluoride (115608). A cohort study in Mexico found that higher urinary fluoride levels during pregnancy are associated with symptoms of inattention in the offspring at age 6-12 years (103550). Conversely, a cohort study conducted in Denmark identified no relationship between maternal urinary fluoride levels and IQ score at 7 years of age (115602). The findings of these studies are limited by the use of urinary fluoride levels, which are considered a potentially unreliable marker of fluoride intake. In fact, one study investigating the impact of diet on urinary fluoride levels during pregnancy identified potential variations in impact between trimesters and between the pre- and postpartum states (115609).
Other ...Population research in adolescents has found that having plasma fluoride levels of at least 0. 32 micromol/L or consuming water with fluoride levels of at least 0.73 mg/L increases the odds of hyperuricemia by approximately 1.8-fold when compared with the lowest quartiles. In addition, serum uric acid levels are increased by 0.212 mg/dL for each micromol/L increase in plasma fluoride levels (107645).
