dependancy SF Gel Generic Name: sodium fluoride Dosage Form: gel Side Effects Dosage Professional Pregnancy Reviews More Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. 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. This prescription product is not a dentifrice. Active Ingredient: Sodium Fluoride, USP 1.1% (w/v). Slideshow Sexual Health Q+A: Your Questions Answered Inactive Ingredients Purified Water, Sorbitol, Hydroxyethylcellulose, Flavor, Poloxamer 407, Sodium Saccharin, Methylparaben, Propylparaben, FD&C Blue No. 1. SF Gel - 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 for SF Gel 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 SF 1.1% Brush-On Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a 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.) Contraindications Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. Warnings 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. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel which could cause dental fluorosis. Read directions carefully before using. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. 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 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 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. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride 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 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 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 years conducted by Englander, et al. 2,3,4 . 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. 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 and 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 emesis, 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 SF 1.1% Brush-On Gel contains 2 mg flouride. A 2 oz. tube contains 266 mg fluoride. SF Gel Dosage and Administration Follow these instructions unless otherwise instructed by your dental professional: 1. After brushing thoroughly with toothpaste, rinse as usual. 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. 2. After use, adults expectorate gel. For the best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate gel after use and rinse mouth thoroughly. How is SF Gel Supplied 2 oz. (56g) net wt. plastic tube. Flavor: Fresh Mint NDC 60258-151-01 STORAGE Store at Controlled Room Temperature, 20 o -25 o C (68 o -77 o F). Rx only REFERENCES 1. American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407 (1984). 2. H.R. Englander et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 75, 638-644 (1967). 3. H.R. Englander et al., Residual Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 78, 783-787 (1969). 4. 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). You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Cypress Pharmaceutical, Inc. at 1-800-793-2145 or FDA at 1-800-FDA-1088 (Toll Free). Manufactured for: Cypress Pharmaceutical, Inc., Morristown, NJ 07960 P166 Rev. 6/2016 504433 PRINCIPAL DISPLAY PANEL - 56 g Tube Carton FRESH MINT Rx ONLY NDC 60258-151-01 SF 1.1% GEL 1.1% SODIUM FLUORIDE Brush-on Gel (non-abrasive formula) CYPRESS PHARMACEUTICAL, INC. NET WT. 2 OZ. (56 g) SF 1.1% sodium fluoride gel Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60258-151 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 11 mg in 1 g Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) SACCHARIN SODIUM METHYLPARABEN SORBITOL WATER POLOXAMER 407 PROPYLPARABEN FD&C BLUE NO. 1 Product Characteristics Color blue Score Shape Size Flavor MINT (FRESH MINT) Imprint Code Contains Packaging # Item Code Package Description 1 NDC:60258-151-01 1 TUBE in 1 CARTON 1 56 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/1999 Labeler - Cypress Pharmaceutical, Inc. (790248942) Registrant - Cypress Pharmaceutical, Inc. (790248942) Establishment Name Address ID/FEI Operations Faria Limited dba Sheffield Pharmaceuticals 151177797 manufacture(60258-151) Revised: 07/2016 Cypress Pharmaceutical, Inc. Next Pregnancy Warnings Print this page Add to My Med List More about SF Gel (fluoride topical) Side Effects During Pregnancy Dosage Information Support Group 0 Reviews Add your own review/rating Consumer resources Professional resources Stannous Fluoride Oral Rinse (FDA) Other brands: Prevident 5000 Plus , Fluoridex , SF 5000 Plus , Clinpro 5000 , ... +52 more Related treatment guides Prevention of Dental Caries} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Related Drugs Prevention of Dental Caries Biotene , Prevident , fluoride topical , Prevident 5000 Plus , Denta 5000 Plus , SF , Fluoridex , SF 5000 Plus , Dentagel , Clinpro 5000 , PreviDent 5000 Booster , Gelato X , Prevident 5000 Sensitive , Zooby , ACT Fluoride Rinse , Neutral Sodium Fluoride Rinse , Flura-Drops , Prevident Mouthwash , Perio Med , VividSensiGuard , Colgate Total Advanced Clean , More... 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