Ideal home therapy for the adult patient. Brush thoroughly once daily for two minutes, preferably at bedtime. 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. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Colgate® Wave™ Toothbrush has a curved handle to fit your patient's hand snugly and comfortably for brushing control. Keep out of reach of infants and children. PreviDent® 5000 Booster Plus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. Our Bright Smiles, Bright Futures program brings oral health education to more than half a billion children around the world. Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Read directions carefully before using. Have questions about your smile? (51g) tubes, Prescription-strength fluoride toothpaste, Significant remineralization of root caries in just 3 months (38%) and 6 months (57%)1, One-step procedure, better patient compliance, Therapeutic decay prevention safe for exposed root surfaces. These symptoms may persist for 24 hours. *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. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. Angled bristles reach interproximally to clean away plaque. 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. Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. In vivo data are conflicting. Pediatric Use: The use of PreviDent® 5000 Booster Plus 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 to 14 years conducted by Englander et al.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. 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. There are no adequate and well-controlled studies in pregnant women. A dental caries preventive; for once daily self-applied topical use. 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. It combines the cleaning power of a toothpaste with prescription-strength fluoride for dental-caries protection. © YYYY Colgate-Palmolive Company. Colgate® Duraphat® 5000ppm Fluoride 1 g of toothpaste contains 5 mg Fluoride (as Sodium Fluoride), corresponding to 5000 ppm Fluoride. Medicinal product subject to medical prescription. 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. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. 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. 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. 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). Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. 3.4 fl. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood. Follow these instructions unless otherwise instructed by your dental professional: Spearmint - NDC 0126-0287-66 Fruitastic™ - NDC 0126-0288-66, Twin Pack (two 1.8 oz. COLGATE® DURAPHAT® 5000PPM FLUORIDE TOOTHPASTE IS A MEDICALLY LICENSED PRESCRIPTION ONLY TOOTHPASTE. No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. 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. 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. In vitro standard method for enamel fluoride uptake. 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. Ergonomically designed for comfortable brushing. American Dental Association, Accepted Dental Therapeutics Ed. Pregnancy: Teratogenic Effects: Pregnancy Category B. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly. tubes). 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. (51g) net wt. A treatment dose (a thin ribbon) of PreviDent® 5000 BoosterPlus contains approximately 2.5 mg fluoride. Reversal of primary root caries using dentifrices containing 5,000 and 1,100 ppm fluoride. Brush teeth thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste. Nursing Mothers: It is not known if fluoride is excreted in human milk. All Rights Reserved. DO NOT SWALLOW. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. 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.