Each one mL serving contains: Sodium Fluoride (0.5 mg fluoride ion) 1.1 mg. Inactive Ingredients: Purified Water, Sorbitol Solution 70%, Propylene Glycol, Methyl Paraben, Flavor, Propyl Paraben, Magnasweet-110, FD&C Yellow No. 6.
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Below is general information about the effectiveness of the known ingredients contained in the product Luride Drops. 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 Luride Drops. 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).
Below is general information about the interactions of the known ingredients contained in the product Luride Drops. 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 Luride Drops. 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).
