Water • Hydrated Silica • Glycerin • Xylitol • Titanium Dioxide • Aroma • Xanthan Gum • Sodium Lauroyl Sarcosinate • Sodium Fluoride (0.24%) • Sodium Methylparaben • Sodium Ethylparaben • Sodium Propylparben • Sodium Propylparben .
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Below is general information about the effectiveness of the known ingredients contained in the product Xylibrush 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
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Xylibrush 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 with apparent safety for many years, some population research suggests that more information is needed to determine a safe level of fluoride exposure in infants and children living in regions with fluoridated water. Population research has found an association between urinary fluoride levels and diagnosis of ADHD with higher inattention scores at age 14 years, but not at age 9 years (103551). Also, 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). More research is needed to determine whether these effects are due to fluoride or to confounding factors such as socioeconomic status, use of formula instead of breast-feeding, parental intelligence, choice of IQ tests used in studies, and other factors (103542,103544). ...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).
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 fluoride intake during pregnancy, from appropriately fluoridated water or fluoridated salt, 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, parental intelligence, choice of IQ tests used in studies, and other factors (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).
LIKELY SAFE ...when used rectally and appropriately. Glycerol rectal suppositories and enemas are approved by the US Food and Drug Administration (FDA) for over-the-counter use to treat occasional constipation (15,272). ...when used topically and appropriately as a lotion, emulsion, or humectant (15,272,93754,93758,93759,99164).
POSSIBLY SAFE ...when used orally, short-term. Glycerol has been used with apparent safety in clinical trials at doses of up to 1.5 grams/kg (2474,2475,99162).
POSSIBLY UNSAFE ...when used intravenously. While some research suggests that intravenous glycerol can be safely administered for two consecutive days twice monthly for up to 6 months (106649), in another study, hemolysis was reported in 98% of patients treated with intravenous glycerol for acute ischemic stroke (2482).
CHILDREN: LIKELY SAFE
when used rectally and appropriately.
Glycerol rectal suppositories and enemas are approved by the US FDA for over-the-counter use to treat occasional constipation in children 2 years of age and older (15,272). ...when used topically and appropriately as an emulsion or humectant in children 1 month of age and older (15,272,93756).
CHILDREN: POSSIBLY SAFE
when used orally, short-term.
Glycerol has been used with apparent safety in clinical trials in children 2 months to 16 years of age at doses of 1.5 gram/kg, up to a maximum dose of 25 grams, taken every 6 hours (93762,93763).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods (7135,10470,92135). It is estimated that the average dietary intake of silicon is 20-50 mg daily (110029); however, there is currently no established recommended dietary allowance or tolerable upper intake level for silicon (7135,92136,95009,110029).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (7135,10470).
It is estimated that the average dietary intake of silicon is 20-50 mg daily (110029). There is insufficient reliable information available about the safety of silicon when used in larger, medicinal amounts; avoid using.
LIKELY SAFE ...when consumed in amounts found in foods, up to 10 mg/kg per day (4914). It has Generally Recognized as Safe (GRAS) status in the US (4912). ...when used orally for medicinal use in amounts up to 15 grams per day (4914,4916,4917,4918). ...when used topically and appropriately (4914,89591,95794).
PREGNANCY AND LACTATION:
Insufficient reliable information is available; avoid using in amounts greater than those found in foods.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Xylitol is an approved food additive in the US (17915).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts as a chewing gum, candy, lozenge, toothpaste, or mouth rinse. Xylitol has been used with apparent safety in doses of 20-53 grams daily for up to 3 years (6815,6819,6821). ...when used as nasal irrigation 1-3 times daily for up to 30 days (95115,95122,103889,105981). ...when inhaled via nebulizer. 5 mL of xylitol 15% solution has been used with apparent safety twice daily for up to 2 weeks (103888).
POSSIBLY UNSAFE ...when used orally in very high doses, long-term. There is some concern that very high doses for extended periods of use can induce tumor growth (6815,6820). However, this effect has not yet been demonstrated in humans.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts as a chewing gum, candy, lozenge, toothpaste, or mouth rinse.
Xylitol has been used with apparent safety in doses up to 20 grams daily for up to three years (6815,6819).
PREGNANCY AND LACTATION:
There insufficient reliable information available about the use of xylitol in medicinal amounts during pregnancy and lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Xylibrush 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.
Theoretically, xanthan gum can alter the absorption of oral drugs due to its fiber qualities. Xanthan gum slows gastric emptying and has been used to control the release of drugs in tablet formulations (4916,104058). To avoid any alterations in drug absorption, xanthan gum should be taken 30-60 minutes after oral medications.
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Below is general information about the adverse effects of the known ingredients contained in the product Xylibrush 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).
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).
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).
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
...Exposure to high levels of natural fluoride during neurodevelopment in childhood is associated with a decreased IQ score.
This relationship has been shown in numerous population studies comparing areas with water containing high levels of natural fluoride (e.g. up to 11.5 mg/L) with the standard concentrations (0.7-1.2 mg/L) normally found in fluoridated water (94401,103544). 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 some concern that levels of fluoride found in optimally fluoridated water sources might also impact neurodevelopment during infancy or childhood. For example, population research in Canada has 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. At 14 years, the predicted odds of an ADHD diagnosis was 2.8 times greater than the odds for youth in non-fluoridated regions (103551). In addition, in infants under 6 months of age using formula as the main source of energy, there is some concern that reconstitution of 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).
There is also some concern that levels of fluoride found in optimally fluoridated water sources might impact fetal neurodevelopment. Emerging population research found that increased fluoride intake during pregnancy, from appropriately fluoridated water or fluoridated salt, might be associated with negative cognitive effects. One observational study in Canada 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). Another study found that increased exposure to fluoride during pregnancy is associated with symptoms of inattention in the offspring at age 6-12 years (103550).
The findings of these studies are interesting and support further research. More information is needed to know if these results are clinically significant at the population level (103548,103549,103550). In addition, although effort was made to take confounding factors into consideration, more information is needed to determine whether these neurological effects are related to fluoride exposure during pregnancy or to other factors such as socioeconomic status, use of formula instead of breast-feeding, parental intelligence, choice of IQ tests used in studies, and others. Also, the actual intake of fluoride was not known in most cases (94401,103542,103544,103546,103547,103548,103549,103550).
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 icromole/L increase in plasma fluoride levels (107645).
General
...Orally, rectally, and topically, glycerol seems to be well tolerated.
Intravenously, glycerol may be unsafe.
Most Common Adverse Effects:
Orally: Bloating, diarrhea, nausea, vomiting, dizziness, and headache.
Topically: Burning, irritation, and pruritus.
Intravenously: Hemolysis in patients with acute ischemic stroke.
Dermatologic ...Topically, glycerol has been reported to cause burning, irritation, and pruritus (93754,93756). Rectally, the regular administration of glycerol 50% enemas has been reported to cause generalized urticaria in at least two patients; in both patients, symptoms resolved after discontinuation (110019,110025).
Gastrointestinal ...Orally, glycerol can cause bloating, nausea, vomiting, thirst, and diarrhea (15,2475).
Hematologic ...Intravenously, glycerol has been reported to caused hemolysis in people treated for acute ischemic stroke (2480,2482).
Neurologic/CNS ...Orally, glycerol can cause mild headache and dizziness (15,2475).
General
...Orally, silicon in the amounts found in food and water is not associated with adverse effects.
Serious Adverse Effects (Rare):
Inhaled: Crystalline silicon dioxide in the form of quartz dust found in industrial and occupational settings is associated with an increased risk of diseases such as silicosis, tuberculosis, chronic bronchitis, chronic obstructive pulmonary disease (COPD), lung cancer, glomerulonephritis, vasculitis, and rheumatoid arthritis.
Cardiovascular ...Case control studies have shown that occupational exposure to silicon dioxide-containing compounds may cause vasculitis (75114). Patients with occupational pulmonary silicosis may develop microscopic polyangiitis (inflammation of the blood vessels in the nose, sinuses, throat, lungs, and kidneys, also known as Wegener's granulomatosis).
Dermatologic ...Occupational silica exposure may be a risk factor for scleroderma, particularly in males (75099).
Genitourinary
...Limited reports in humans indicate that long-term use of large amounts of antacids containing magnesium trisilicate may be associated with urolithiasis and silicon-containing stones (11760,11861,75075,75103).
However, fewer than 30 cases associated with antacids containing silicates have been reported, despite these products being commercially available since the 1930s. Although exceptionally rare, silicon dioxide kidney stones can also occur without magnesium trisilicate ingestion (11556). Their formation is caused by an acidic urinary pH. In at least one case, urine alkalinization resulted in resolution of the symptoms (75075).
Case-control studies have shown that occupational exposure to silicon dioxide is related to antineutrophil cytoplasmic antibody (ANCA)-associated glomerulonephritis (75114). High silicon levels in patients undergoing chronic hemodialysis have been associated with nephropathy (75089).
Hepatic ...High silicon levels in patients undergoing chronic hemodialysis have been associated with liver disease (75089).
Musculoskeletal ...High silicon levels in patients undergoing chronic hemodialysis have been associated with bone disease (75089). A meta-analysis suggests that the risk of rheumatoid arthritis is elevated with occupational exposure to silicon dioxide (75078).
Neurologic/CNS ...High silicon levels in patients undergoing chronic hemodialysis have been associated with neuropathy (75089).
Pulmonary/Respiratory ...Occupational exposure to crystalline silicon dioxide dust is associated with an increased risk of pulmonary diseases such as silicosis, tuberculosis, chronic bronchitis, chronic obstructive pulmonary disease (COPD), and lung cancer (75076,75081,75084,75114). Patients with occupational pulmonary silicosis may develop microscopic polyangiitis (inflammation of the blood vessels in the nose, sinuses, throat, lungs, and kidneys, also known as Wegener's granulomatosis). Meta-analyses suggest that occupational exposure to silicon dioxide increases the risk of lung cancer (75085,75095,75115). An analysis of 19 studies shows that lung cancer risk is approximately 2 times higher for those with silicosis (75115). It is not clear whether silicon dioxide is carcinogenic in the absence of silicosis (75083).
General ...Orally, xanthan gum can cause flatulence and abdominal distention (4916,4918). Topically, it has been reported to cause allergic reactions (100914).
Immunologic ...An itchy, burning dermatitis was reported in a 9-year old girl after application of a sunscreen product containing xanthan gum. Patch testing with the separate ingredients of the sunscreen identified xanthan gum as the reacting agent, and demonstrated a dose-dependent effect with 1% and 10% solutions (100914).
Pulmonary/Respiratory ...Occupational exposure in workers handling xanthan gum powder can cause flu-like symptoms and nose and throat irritation without acute or chronic loss of pulmonary function (4913).
General
...Orally, xylitol is generally well tolerated in food amounts, although it may cause gastrointestinal discomfort at high doses.
Topically, xylitol seems to be well tolerated.
Most Common Adverse Effects:
Orally: With high doses (30-40 grams), bowel sounds, diarrhea, flatulence.
Topically: Stinging of mucous membranes.
Endocrine ...Orally, high doses of xylitol can increase the risk of hyperuricemia. In a small study in healthy adults, taking a single dose of xylitol 35 grams in water increases levels of uric acid, while lower doses of xylitol did not have this effect (105980). Intravenous infusion of high doses of xylitol has been associated with hyperuricemia and acidosis, including lactic acidosis (6815).
Gastrointestinal ...Orally, acute administration of large amounts of xylitol (30 to 40 grams) can cause osmotic diarrhea, nausea, and flatulence (9,112857). However, if the dose is increased gradually, tolerance to this effect can occur and prevent development of diarrhea and flatulence (9).
Hepatic ...Intravenous infusion of high doses has been associated with changes in liver function enzymes (6815).
Immunologic ...There are various cases of suspected allergic reactions to xylitol. In one case, an anaphylactic reaction to xylitol was reported in a 2-year-old. The allergy was confirmed based on a skin-prick test and basophil activation test (100173).
Pulmonary/Respiratory ...Following use of xylitol in nasal irrigation, minor stinging in the nose has been reported (95122,105981).