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CLINICAL PHARMACOLOGY: Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Sodium Fluoride 1.1% Dental Gel in a squeeze-tube is easily applied onto a toothbrush. This prescription dental gel should be used once daily following use of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

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 0.6 ppm, since younger pediatric patients frequently can not perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental gel, which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.

PRECAUTIONS: Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility: 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 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 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 fluoride, 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 aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. 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, fox, 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 concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. Pregnancy: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood. Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use: The use of Sodium Fluoride 1.1% Dental Gel in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al. 2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Carcinogenesis, Mutagenesis, Impairment of Fertility: 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 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 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 fluoride, 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 aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. 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, fox, 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 concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood.

Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use: The use of Sodium Fluoride 1.1% Dental Gel in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al. 2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC. at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of Sodium Fluoride 1.1% Dental Gel contains 2 mg fluoride. A 2 oz. tube contains 255 mg fluoride.

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime. After use, adults expectorate gel. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

<table width="75%" cellspacing="0" cellpadding="0"><tbody><tr styleCode="Botrule First"><td rowspan="2" align="left" styleCode="Lrule Rrule" valign="top"/><td align="left" styleCode="Rrule" valign="top"><content styleCode="bold">HOW SUPPLIED:</content></td><td align="left" styleCode="Rrule" valign="top"><content styleCode="bold">Fresh Mint </content></td><td align="left" styleCode="Rrule" valign="top"/></tr><tr><td align="left" styleCode="Lrule Rrule" valign="top">2 oz. (56g) net wt. tube</td><td align="left" styleCode="Rrule" valign="top">NDC# 35573-435-56</td><td align="left" styleCode="Rrule" valign="top"/></tr></tbody></table>

REFERENCES: American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In:Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407 (1984). H.R. Englander et al., Clinical Anticaries Effects of Repeated Topical Sodium Fluoride Application by Mouthpieces, JADA, 75, 638-644 (1967). H.R. Englander et al., Residual Anticaries Effects of Repeated Topical Sodium Fluoride Application by Mouthpieces, JADA, 78, 783-787 (1969). H.R. Englander et al., Incremental Rates of Dental Caries After Repeated Topical Sodium Fluoride Applications in Children with Lifelong Consumption of Fluoridated Water, JADA, 82, 354-358 (1971).

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minute

Sodium Fluoride Chewable Tablets This insert is for 1.0 mg strength tablets, 0.5 mg strength tablets, and 0.25 mg strength tablets. Rx Only This product is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis. 120 Tablets per bottle Water F¯ Content Ages 0 ppm F¯ to <0.3 ppm F¯ 0.3 ppm F¯ to 0.6ppm F¯ >0.6ppm F¯ 3 yrs. to 6 yrs. 0.5mg* 0.25mg* 0 >6yrs. to 16 yrs. 1.0mg* 0.5mg* 0 * Per day Active Ingredient: Fluoride (as Sodium Fluoride) 0.25 mg / 0.5 mg / 1.0 mg Inactive Ingredients: M icrocrystalline cellulose, D-Mannitol, Sucrose, Stearic acid, Magnesium stearate, Natural Grape flavor. 0.25mg also contains: D&C Red #27 Alum Lake and FD&C Yellow #6 Alum Lake. 0.5 mg also contains: FD&C Red #40 Alum Lake. 1.0 mg also contains: D&C Red #27 and FD&C Blue #1.

<table><col width="192"/><col width="205"/><col width="198"/><col width="132"/><tbody><tr><td colspan="4" align="center" styleCode="Lrule Rrule Toprule" valign="bottom"><content styleCode="bold">Water F&#xAF; Content</content></td></tr><tr><td align="center" styleCode="Lrule Rrule Toprule"><content styleCode="bold">Ages</content></td><td align="center" styleCode="Lrule Rrule Toprule"><content styleCode="bold">0 ppm F&#xAF; to &lt;0.3 ppm F&#xAF;</content></td><td align="center" styleCode="Lrule Rrule Toprule"><content styleCode="bold">0.3 ppm F&#xAF; to 0.6ppm F&#xAF;</content></td><td align="center" styleCode="Lrule Rrule Toprule"><content styleCode="bold">&gt;0.6ppm F&#xAF;</content></td></tr><tr><td align="center" styleCode="Lrule Rrule Toprule" valign="bottom">3 yrs. to 6 yrs.</td><td align="center" styleCode="Lrule Rrule Toprule" valign="bottom">0.5mg*</td><td align="center" styleCode="Lrule Rrule Toprule" valign="bottom">0.25mg*</td><td align="center" styleCode="Lrule Rrule Toprule" valign="bottom">0</td></tr><tr><td align="center" styleCode="Lrule Rrule Toprule" valign="bottom">&gt;6yrs. to 16 yrs.</td><td align="center" styleCode="Lrule Rrule Toprule" valign="bottom">1.0mg*</td><td align="center" styleCode="Lrule Rrule Toprule" valign="bottom">0.5mg*</td><td align="center" styleCode="Lrule Rrule Toprule" valign="bottom">0</td></tr></tbody></table>

CLINICAL PHARMACOLOGY Sodium Fluoride acts systemically (before tooth eruption) and topically (post-eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process.

INDICATIONS AND USAGE For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F¯) during the period of tooth development results in a significant decrease in the incidence of dental caries. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯.

CONTRAINDICATIONS Fluoride 1.0 mg Tablets are contraindicated when the fluoride content of drinking water is >0.3 ppm F¯ and should not be administered to pediatric patients under 6 years. Fluoride 0.5 mg Tablets are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F¯ and should not be administered to pediatric patients under age 6 when the fluoride content of drinking water is 0.3 ppm F¯ or more or to pediatric patients under age 3 years. Fluoride 0.25 mg Tablets are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F¯ and should not be administered to pediatric patients under age 3 years when the fluoride content of drinking water is 0.3 ppm F¯ or more. Do not administer Sodium Fluoride Chewable Tablets (any strength) to pediatric patients under age 3 years. Sodium Fluoride Chewable Tablets (any strength) are not indicated for use in adults.

OVERDOSAGE Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A bottle of 120 0.25 mg tablets contains 30 mg fluoride. A bottle of 120 0.5 mg tablets contains 60 mg fluoride. A bottle of 120 1 mg tablets contains 120 mg fluoride. [The total amount of sodium fluoride in a bottle of 120 Fluoride Chewable Tablets (all strengths) conforms with the recommended amount of the American Dental Association for the maximum to be dispensed at one time for safety purposes.]

WARNING Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. This product, as all chewable tablets, is not recommended for children under age 3 due to risk of choking. Keep out of the reach of infants and children.

PRECAUTIONS General Please refer to the CONTRAINDICATIONS , WARNINGS and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 3 years is not recommended by current American Dental Associations and American Academy of Pediatrics guidelines. Drug Interactions: Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Carcinogenesis, Mutagenesis, Impairment of Fertility In a study conducted in rodents, no carcinogenesis was found in male and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 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. This dose is at least 400 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodentcells at does much higher than those to which humans are exposed. In vivo data is conflicting. 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 has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, 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 doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. This dose is approximately 200 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Pregnancy Teratogenic Effects Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Nursing Mothers It is not known if fluoride is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Sodium Fluoride Chewable Tablets are administered to a nursing woman. Reduced milk production was reported in farm raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. This dose is at least 200 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Geriatric Use Sodium Fluoride Chewable Tablets (any strength) are not indicated for use in geriatric patients.

ition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. This dose is at least 200 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Geriatric Use Sodium Fluoride Chewable Tablets (any strength) are not indicated for use in geriatric patients. Pediatric Use The use of Sodium Fluoride Chewable Tablets as a caries preventive in pediatric age groups 3 years to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence.

General Please refer to the CONTRAINDICATIONS , WARNINGS and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 3 years is not recommended by current American Dental Associations and American Academy of Pediatrics guidelines. Drug Interactions: Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

Drug Interactions: Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

Carcinogenesis, Mutagenesis, Impairment of Fertility In a study conducted in rodents, no carcinogenesis was found in male and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 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. This dose is at least 400 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodentcells at does much higher than those to which humans are exposed. In vivo data is conflicting. 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 has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, 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 doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. This dose is approximately 200 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets.

Pregnancy Teratogenic Effects Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers It is not known if fluoride is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Sodium Fluoride Chewable Tablets are administered to a nursing woman. Reduced milk production was reported in farm raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. This dose is at least 200 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets.

Pediatric Use The use of Sodium Fluoride Chewable Tablets as a caries preventive in pediatric age groups 3 years to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence.

HOW SUPPLIED 120 count Chewable tablets Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. Pink-colored, grape flavor, un-scored, round chewable tablet, debossed with "WL" "163" on one side and plain on other side of tablet. NDC 75826-163-20 (120 count). Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. Peach-colored, grape flavor, un-scored, round chewable tablet, debossed with “WL" "164” on one side and plain on other side of tablet. NDC 75826-164-20 (120 count). Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. Purple-colored, grape flavor, un-scored, round chewable tablet, debossed with “WL” “165” on one side and plain on other side of tablet. NDC 75826-165-20 (120 count).

STORAGE Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Warning: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.