SF Gel Description Self-topical neutral fluoride gel containing 1.1% (w/v) sodium fluoride for use as a dental caries preventive in pediatric patients and adults. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Self-topical neutral fluoride gel containing 1.1% (w/v) sodium fluoride for use as a … tube contains 255 mg fluoride. water (purified), sorbitol, hydroxyethylcellulose, flavor, poloxamer 407, sodium saccharin, methylparaben, propylparaben, FD&C Blue No.1. Englander et al., Residual Anticaries Effects of Repeated Topical Sodium Fluoride Application by Mouthpieces, JADA, 78, 783-787 (1969). burelpharma NDC 35573-435-56, Prescription Brush-on Gel (non-abrasive formula), Other brands: Prevident 5000 Plus, Clinpro 5000, Dentagel, SF 5000 Plus, ... +54 more, Prevident 5000 Plus, Denta 5000 Plus, Biotene, Clinpro 5000, Dentagel, SF 5000 Plus. HOW TO USE: Depending on the product, this medication is applied onto the teeth, either with a mouth tray or a small brush/swab, by a dental professional. 3. The use of SF 1.1% Brush-On 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 … However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. 2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. 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. If using the gel… For further information about unapproved drugs, click here. 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. 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. Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. H.R. Available for Android and iOS devices. DO NOT SWALLOW. Sodium fluoride makes teeth more resistant to decay and bacteria that cause cavities. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 SF 1.1% Brush-On Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription product is not a dentifrice. Not for systemic treatment. 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). Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. Medically reviewed by Drugs.com. Select one or more newsletters to continue. DESCRIPTION:. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. Colgate, PPAX1176035, Gel-Kam Fluoride Preventive Treatment, Gel Mint Flavor, 4.30 Ounce Tube, 1 … Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental gel, which could cause dental fluorosis. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. After brushing thoroughly with toothpaste, rinse as usual. Reduced milk production was reported in farm-raised fox when animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). A treatment dose (a thin ribbon) of Sodium Fluoride 1.1% Dental Gel contains 2 mg fluoride. SODIUM FLUORIDE (SOE dee um FLOOR ide) gel is used to prevent tooth decay. 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. For best results, do not eat, drink, or rinse for 30 minutes. Englander et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 75, 638-644 (1967). H.R. 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. Sodium Fluoride 1.1% Dental Gel Tube 56 Gram Cypress Pharmaceutical 60258015101 Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Consumer information about the medication SODIUM FLUORIDE 1.1% DENTAL GEL - TOPICAL (Karidium, Karigel, Prevident), includes side effects, drug interactions, recommended dosages, and storage information. Denti-Care Denti-Foam Topical Sodium Fluoride Foam. Englander et al., Clinical Anticaries Effects of Repeated Topical Sodium Fluoride Application by Mouthpieces, JADA, 75, 638-644 (1967). These symptoms may persist for 24 hours. Pregnancy Category B. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. 40, Chicago, ADA, 405-407 (1984). 1-4 PreviDent® Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Consumer information about the medication SODIUM FLUORIDE 1.1% DENTAL GEL - TOPICAL (Karidium, Karigel, Prevident), includes side effects, drug interactions, recommended dosages, and storage information. May be used whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. 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. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. This medication is used to prevent cavities. Dosage Form: gel. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Keep out of reach of infants and children. Medically reviewed by Drugs.com. Faria Limited dba Sheffield Pharmaceuticals. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce emesis, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance.
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