Colgate® PreviDent® brush-on gel is a 1.1% neutral sodium fluoride brush-on gel designed for at-home use by all patients who require extra-strength fluoride protection. After use, adults expectorate. 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. Ask the Colgate Chatbot! Colgate® Duraphat® 5000ppm fluoride toothpaste is a high fluoride toothpaste for the prevention of dental caries in adults over 16 years — particularly amongst patients at high risk from caries (coronal and/or root caries). 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. In vivo data are conflicting. 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. 5-7 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.4-7PreviDent 5000 Plus (Rx) brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. Baysan A et al. Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. 40 (Chicago, 1984): 405-407. Read directions carefully before using. 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. Daily consumption of non-diet soft drinks for 12 to 19 year olds at least doubled between 1977 and 1994, Laboratory tests show sugary sodas eat away at tooth enamel, An estimated one quarter of school-aged children experience three quarters of the general population's dental decay. A dental caries preventive; for once daily self-applied topical use. It combines the cleaning power of a toothpaste with prescription-strength fluoride for dental-caries protection. DO NOT SWALLOW. These symptoms may persist for 24 hours. 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 PreviDent® 5000 Booster Plus to a toothbrush. (See WARNINGS for exception.). However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Fluoride ion is not mutagenic in standard bacterial systems. Delivers four times the fluoride of over-the-counter toothpastes and rinses for unsurpassed cavity protection1, Significant remineralization of root caries in as little as 3 months (38%) and 6 months (57%)2. Please refer to the CONTRAINDICATIONS and WARNINGS sections. 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 cannot perform the brushing process without significant swallowing. Pediatric patients under age 12 should be supervised in the use of this product. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly. COLGATE® DURAPHAT® 5000PPM FLUORIDE TOOTHPASTE IS A MEDICALLY LICENSED PRESCRIPTION ONLY TOOTHPASTE. 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. Pregnancy: Teratogenic Effects: Pregnancy Category B. *In the U.S., Fruitastic is a licensed trademark of National Fruit Products Co., Inc. A dental caries preventive; for once daily self-applied topical use. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. These symptoms may persist for 24 hours. 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). 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. (100 mL) in plastic bottles Spearmint: NDC 0126-0075-92 Fruitastic**: NDC 0126-0076-92, Store at controlled room temperature, 20-25°C (68-77°F). Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste, which could cause dental fluorosis. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood. After use, adults expectorate. Ideal home therapy for the adult patient. Pediatric Use: The use of PreviDent 5000 Plus (Rx) in pediatric groups age 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 to 14 years conducted by Englander et. Our Commitment. In vitro standard method for enamel fluoride uptake. 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. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. Keep out of reach of infants and children. Reversal of primary root caries using dentifrices containing 5,000 and 1,100 ppm fluoride. Colgate Reaches Children in Need Across the Globe With the Power of a Bright Smile. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. A treatment dose (a thin ribbon) of PreviDent® 5000 BoosterPlus contains approximately 2.5 mg fluoride. There are no adequate and well-controlled studies in pregnant women. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Young patients will flip over PreviDent 5000 Plus Fruitastic*.™, © Colgate-Palmolive Company 2019. 1 Joziak MT, et al. tubes). It is quick and easy to apply, and sets rapidly in contact with saliva, resulting in patient comfort and acceptance. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. General: Not for systemic treatment. 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. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Brush thoroughly once daily for two minutes, preferably at bedtime. 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 cannot perform the brushing process without significant swallowing. Treating carries as an Infectious disease. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood. Read directions carefully before using. All Rights Reserved. ADA Council on Access, Prevention and Interprofessional Relations. Brush teeth thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste.
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