The use of Sodium Fluoride 5000 ppm 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. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. Fluoride ions are excreted mainly in urine, but small amounts may also be excreted in faeces and sweat. An increased number of potential fluoride sources may lead to fluorosis. A dental caries preventive; for once daily self-applied topical use. Compare Fluoride vs Prevident 5000 Plus head-to-head with other drugs for uses, ratings, cost, side effects and interactions. 4.2 Posology and method of administration Fluoride 5000 ppm Toothpaste is contraindicated in children and adolescents aged under 16 years, see section 4.3. Save 5% more with Subscribe & Save. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. Potassium Nitrate 5% Antisensitivity. Fluoride Toothpaste, Cool Peppermint, 4.7 oz. This site uses cookies. Labeler Name: Sheffield Pharmaceuticals Llc Save 5% more with Subscribe & Save "toothpaste" Colgate Max White Sparkle Diamonds Toothpaste, Spearmint, 75 ml. 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. This product contains sodium benzoate. For doctors to recommend 5,000 PPM ‘fluoride enhanced’ toothpaste is absolutely insane. Department. Frequency not known (cannot be estimated from the available data): burning oral sensation, Rare (> 1/10,000, < 1/1,000): hypersensitivity reactions. Morningside Healthcare Ltd contact details. "colgate duraphat 5000 toothpaste" REGENERATE™ Advanced Toothpaste – Clinically proven - remineralize tooth enamel for strong, healthy teeth 75ml . Tube                                                 NDC  #11527-750-43 SPEARMINT. 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system, the Yellow card scheme at: www.mhra.gov.uk/yellowcard. There is no adequate data from the use of Fluoride 5000 ppm Toothpaste in lactating women, and it is unknown if fluoride is excreted in breast milk. OTC - ACTIVE INGREDIENT SECTION. The toxic dose, i.e the lowest dose at which symptoms of intoxication can be induced, is 5 mg fluoride per Kg body weight. Fluoride 5000 ppm Toothpaste. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. 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 5000 ppm dental cream 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. For the full list of excipients, see section 6.1. The mean fluoride concentrations increased in both mucosa and saliva following a single brushing with both 1,450 ppm (meanmuc1,450 (1 h) 1.15 ppm, meansal1,450 (1 h) 0.33 ppm) and 5,000 ppm fluoride toothpaste (meanmuc5,000 (1 h) 3.21 ppm and meansal5,000 (1 h) 0.90 ppm). These symptoms may persist for 24 hours. 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. Therefore this toothpaste should not be used during lactation unless careful risk – benefit assessment has been carried out. This product also contains flavor, FD&C Blue#1(Spearmint only), FD&C Red No. 1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), corresponding to 5000 ppm fluoride, sodium fluoride 1.1 % w/w. £9.20 £ 9. NDC 48878-3101-6. This information is intended for use by health professionals. This product contains sorbitol solution. Englander, HR, Keyes et al:JADA 75: 638-644, 1967. & Articles, All Oral Care Products; Toothpaste; Dental Sensitivity Treatments; Professional Dental Supplies; Fluoride Gels & Foams; See All 7 Departments. Brush carefully, on a daily basis, three times daily, following each meal: - Apply a 2 cm ribbon of toothpaste onto the toothbrush for each brushing. Studies in animals have shown reproductive toxicity of sodium fluoride only when administered at very high levels (see section 5.3). Duraphat® 5000 ppm Fluoride Toothpaste (sodium fluoride) The name of this product is Duraphat® 5000 ppm Fluoride Toothpaste but will be called Duraphat® Toothpaste throughout this leaflet. Colgate ® Duraphat ® 5000 ppm Fluoride Toothpaste – Name of the medicinal product: Duraphat ® 5000 ppm Fluoride Toothpaste. Ingested fluride is converted to hydrofluoric acid. Bone fluorosis (osteosclerosis) will only be seen where there is high chronic absorption of fluoride (over 8 mg daily). Smooth, blue coloured translucent paste with the odour and taste of spearmint. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Sodium Fluoride 1.1% Anticavity . The volume of distribution is 1 L / Kg. 40, ADA, Chicago. Files, Presentations Polyethylene/copolymer/aluminium/copolymer/polyethylene laminated tube with a polypropylene flip top closure. The use of  Sodium Fluoride 5000 ppm 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. This product requires no special storage conditions. Prevention of dental caries in adolescents and adults, particularly amongst patients at risk from multiple caries (coronal and / or root caries). Fluoride rated 3.0/10 vs Prevident 5000 … Englander, HR, et al:JADA 83: 354-358, 1971. Date of first authorisation/renewal of the authorisation. Avg. In extremely rare cases it can prove fatal. Several 1.1% sodium fluoride toothpaste formulations are currently available in the market and are primarily dispensed through pharmacies. Sodium Fluoride 5000 Ppm Spearmint with NDC 11527-750 is a a human prescription drug product labeled by Sheffield Pharmaceuticals Llc. Sodium benzoate is a mild irritant to the skin, eyes, and mucous membrane. 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. This prescription dental cream should be used once daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. Pediatric patients, ages 6-16, expectorate after use and rinse mouth thoroughly. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Product Number: 733013 733014 733015: 12115: Quantity: 1.8 oz. - The active substance is fluoride (as sodium fluoride). is this? Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Labels, All Index Start typing to retrieve search suggestions. Presence in Breast Milk, Medline Plus, Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. 2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. 51g. Customer Review. Morningside 5000 Toothpaste contains 5000ppm of Sodium fluoride, around four times as much than in normal toothpaste. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. 70 ($0.71/Ounce) $12.37 $12.37. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood. Accepted Dental Therapeutics, Ed. It allows continued monitoring of the benefit/risk balance of the medicinal product. SODIUM FLUORIDE 5000 ppm Prescription Dental Cream. 1g of toothpaste contains 5mg fluoride (as sodium fluoride), corresponding to 5000ppm fluoride. To view the changes to a medicine you must sign up and log in. sodium fluoride; Legal Category. Get Label RSS Feed, For best results, do not eat, drink, or rinse for 30 minutes. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. Events, 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. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 4.7 out of 5 stars 2,374. Biochemical Data Summary. P. 405-407, 1984. Sodium Fluoride 5000 ppm Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush. Not for systemic treatment. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream, which could cause dental fluorosis. Enamel roughness (Ra parameter) by contact profilometer at baseline and after exposure onto soft drinks and slurry was measured. (current), sodium fluoride 1.1 % (fluoride ion 0.5 % ) Toothpaste. SODIUM FLUORIDE 5000 PPM SPEARMINT- sodium fluoride paste, dentifrice, 11527-730-44, There is no adequate data from the use of Fluoride 5000 ppm Toothpaste in pregnant women. $6.70 $ 6. The generic name of Sodium Fluoride 5000 Ppm Spearmint is sodium fluoride. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. Same active ingredients; Same company; Bookmark; Email; SmPC; Patient Leaflet; Last updated on emc: 20 Oct 2020. Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Also, standard FD (1,100 ppm F) in combination with professional fluoride application has been recommended to control dentine caries, but the effect of t … Read all of this leaflet carefully before you start using this medicine. 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). At 6 h, the fluoride concentrations had returned to pre-brushing levels. Clinical Trials, Adult and adolescents and children aged 16 years or more: To be used three times daily, after each meal., while brushing the teeth. Follow these instructions unless otherwise instructed by your dental professional: 3.4 FLOZ (100ml) NET WT. A dental caries preventive; for once daily self-applied topical use. All customers get FREE Shipping on orders over $25 shipped by Amazon. In contrast, toothpastes containing over 5,000 ppm of fluoride ion, or 1.1 % sodium fluoride, are available only as prescription products provided by registered dental professionals. Use by children and adolescents aged under sixteen years, see section 4.2. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Therefore this toothpaste should not be used during pregnancy unless careful risk – benefit assessment has been carried out. To bookmark a medicine you must sign up and log in. - A bactericidal effect upon dental plaque organisms. DO NOT SWALLOW. In order to prevent the accumulation of fluoride, the total fluoride intake must be assessed before this fluoride toothpaste is ever used. Systemic fluoride supplements are believed also to act mainly topically (i.e during ingestion, via saliva). Tube                                                 NDC  #11527-730-44 FRUIT, 3.4 FLOZ (100ml) NET WT. 3M ESPE. 33 (Fruit only). April 1, 2020. Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Files, All Mapping Copy the URL below and paste it into your RSS Reader application. If you are a consumer or patient please visit 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. Fluoride 5000 ppm Toothpaste is indicated in adults and adolescents aged 16 years and over. ControlRx ™ Berry. Rx Only . SF 5000 Plus Description Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.