This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. tube contains 255 mg fluoride. Treating carries as an Infectious disease. 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. (See WARNINGS for exception). Young patients will flip over PreviDent 5000 Plus Fruitastic*.™, © Colgate-Palmolive Company 2019. There are no adequate and well-controlled studies in pregnant women. Colgate® PreviDent® 5000 Booster Plus (Rx only), Colgate® PreviDent® 5000 Enamel Protect (Rx only), Colgate® 360°® Fresh 'N Protect™ Tween Toothbrush, Colgate® Gel-Kam® Preventative Treatment Gel, Colgate® Kids Cavity Protection Toothpaste, Colgate® PreviDent® 5000 Dry Mouth (Rx only), Colgate® PreviDent® 5000 Sensitive (Rx only), Colgate® PreviDent® Brush-on Gel (Rx only), Colgate® PreviDent® Dental Rinse (Rx only), Spearmint: twin pack, two 1.8 oz. In vitro standard method for enamel fluoride uptake. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly. J Dent Res. 5-7 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Ideal for patients who desire effective cleaning between teeth. 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). Ask the Colgate Chatbot! Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. Adults and pediatric patients 6 years of age or older: Apply a thin ribbon of PreviDent 5000 Plus (Rx) to a toothbrush. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5. For best results, do not eat, drink, or rinse for 30 minutes. 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. Pregnancy: Teratogenic Effects: Pregnancy Category B. 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. 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. Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Read directions carefully before using. Colgate Reaches Children in Need Across the Globe With the Power of a Bright Smile. Purified water, sorbitol, hydrated silica, PEG-12, tetrapotassium pyrophosphate, sodium lauryl sulfate, mint flavor (Spearmint flavor only), xanthan gum, sodium benzoate, fruit flavor (Fruitastic™* flavor only), sodium saccharin, titanium dioxide (Fruitastic™* flavor only), FD&C Blue #1 (Spearmint flavor only), D&C Red #33 (Fruitastic™* flavor only). 1 Joziak MT, et al. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. 3.4 fl. You are viewing US English site. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. 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. al. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream, which could cause dental fluorosis. In vivo data are conflicting. View our Terms of Use / Privacy Policy / Cookie Policy / Children's Privacy Policy / Do Not Sell My Personal Information / Cookie Consent Tool, Dominican Republic - República Dominicana. Reversal of primary root caries using dentifrices containing 5,000 and 1,100 ppm fluoride. PreviDent® 5000 Booster Plus (1.1% Sodium Fluoride) Prescription Strength Toothpaste (Rx). May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. 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. Our Commitment. 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. PreviDent ® 5000 ppm Ortho Defense (1.1% Sodium Fluoride) Toothpaste. 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. DO NOT SWALLOW. Our Bright Smiles, Bright Futures program brings oral health education to more than half a billion children around the world. Allergic reactions and other idiosyncrasies have been rarely reported. 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. American Dental Association, Accepted Dental Therapeutics Ed. It combines the cleaning power of a toothpaste with prescription-strength fluoride for dental caries protection. Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. A treatment dose (a thin ribbon) of PreviDent 5000 Plus (Rx) contains 2.5 mg fluoride. ADA Council on Access, Prevention and Interprofessional Relations. Ideal therapy for patients with, High cavities risk, Crown and bridge work, Orthodontic decalcification. 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. NDC: 0126-0289-92 Nursing Mothers: It is not known if fluoride is excreted in human milk. Younger patients need fluoride defense. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. 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. 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. (See WARNINGS below for exception.). 2 Data on file; Colgate-Palmolive, 2012. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. PreviDent 5000 Plus (Rx) brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. All rights reserved. Keep out of reach of infants and children. 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. A dental caries preventive; for once daily self-applied topical use. Store at Controlled Room Temperature, 20-25°C (68-77°F). Pregnancy: It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. 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. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. (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). 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.