Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Generic Name: sodium fluoride It is well established that 1.1% sodium fluoride in an acidulated gel is safe and extraordinarily effective as a caries preventive in orthodontic patients when applied frequently with mouthpiece applicators.1,2,3,4,5 Phos-Flur® Gel in a squeeze tube is a particularly convenient dosage form which permits the application of a thin ribbon of gel onto a toothbrush as well as a mouthpiece tray. (56 g) net wt. H.R. Safe, great-tasting and easy to use, Phos-Flur® Rinse provides clinically proven fluoride protection. 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. Talk with the doctor before giving Phos-Flur (sodium fluoride cream, gel, and paste) to a child. Fluoride topical. Mouthwashes & Rinses. 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. Englander et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 75, 638-644 (1967). Use cautiously in patients with porcelain or ceramic restorations as per PRECAUTIONS below. View Products. I'm scared that if I leave it on I might swallow it :(. In vivo data are conflicting. 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. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. Throw away unused or expired drugs. It is not known if fluoride is excreted in human milk. Thanks! Call your doctor for medical 3 Answers. Check with your pharmacist. Some drugs may have another patient information leaflet. The directions tell me to brush my teeth, swish and then spit. 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. If your symptoms or health problems do not get better or if they become worse, call your doctor. A dental caries preventive, for once daily self-applied topical use. If using the gel, apply a pea-sized amount and brush well. Allergic reactions and other idiosyncrasies have been rarely reported. There are many fluoride supplements available in the healthcare market, including such brand names as ACT Fluoride Rinse, Biotene, Clinpro 5000, Control Rx, Denta 5000 Plus, Fluorigard, Fluorinse, Gel-Kam, Nafrinse Solution, Neutracare Gel, Neutragard, Omnii Gel Just For Kids, Oral B Anti-Cavity, OrthoWash, Perfect Choice, Perio Med, or Prevident. These are not all of the side effects that may occur. 10, FD&C blue no.1. tweetyam_06. If using the rinse, swish around for 1 minute before spitting out. Specially formulated for orthodontic patients. Brush as you have been told and then spit out. Favorite Answer. If using the gel… 40, Chicago, ADA, 405-407 (1984). How to use Colgate Phos Flur Rinse? FSA or HSA eligible. 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. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. Available for Android and iOS devices. Tell your Do not place in porcelain or glass containers. Call your doctor or get medical Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Let the drug stay on your teeth for 1 minute before spitting out. Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Order Product. Do not start, stop, or change the dose of American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Medically reviewed by Drugs.com. Contains over four times the fluoride of over-the-counter products; Extra fluoride protection that fits into your daily routine; Precautions: Do not use for children under age 6 unless recommended by a dentist or physician. This is not a list of all drugs or health problems that interact with Phos-Flur (sodium fluoride cream, gel, and paste). If you have any of these health problems: Bone problems, joint problems, kidney problems, or ulcers. Phos-Flur® Gel contains 0.5% fluoride ion (F-) from 1.1% sodium fluoride in an aqueous gel containing 0.1 molar phosphate, pH 5.1. You may report side effects to the FDA at 1-800-332-1088. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. pharmacist if you have questions about the best way to throw out drugs. a subsidiary of Colgate-Palmolive Company For daily self-topical use as a dental caries preventative in adults and pediatric patients age 6 years and over. Ideal home therapy for the adult patient. Keep all drugs in a safe place. Select one or more newsletters to continue. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. You may also report side effects at https://www.fda.gov/medwatch. 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. More Buying Choices $10.22 (12 new offers) Pack of 1. Do not eat, drink, or rinse for at least 30 minutes after using Phos-Flur (sodium fluoride cream, gel, and paste). Read all information given to you. HOW TO USE THIS MEDICATION: This rinse is usually used once or twice a day as directed. H.R. For further information about unapproved drugs, click here. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Tell all of your health care providers that you take Phos-Flur (sodium fluoride cream, gel, and paste). Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. butylparaben, disodium EDTA, ethylparaben, flavor, glycerin, methylparaben, PEG-12, phosphoric acid, poloxamer 407, polysorbate 20, propylene glycol, propyl paraben, sodium benzoate, sodium phosphate, sodium saccharin, water, xanthan gum, D&C yellow no. 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). Mint: NDC 0126-0131-66. $11.98 $ 11. This prescription product is not a dentifrice. Keep all drugs out of the reach of children and pets. We comply with the HONcode standard for trustworthy health information -. Phos-Flur Dental gel 1.1pct Drug Medication Dosage information. Generic Name: Sodium Fluoride Cream, Gel, and Paste (SOW dee um FLOR ide)Brand Name: Phos-Flur, PreviDent. Contact with abraded or sensitive gingival tissue may produce discomfort. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 4.6 out of 5 stars 262. help if you have any side effects that bother you or do not go away. However, many people have no side effects or only have minor side effects. DO NOT SWALLOW. Our Brands. Apply a ribbon of Phos-Flur® Gel to the teeth with a toothbrush or mouthtray for at least one minute. The use of Phos-Flur® 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. Generic Name: fluoride topical (FLOR ide TOP i kal) Brand Name: ACT Fluoride Rinse, Biotene, Clinpro 5000, Denta 5000 Plus, Dentagel, Fluoridex, Fluorigard, Gel-Kam, Neutracare Gel, Neutragard, Neutral Sodium Fluoride Rinse, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Prevident Dental Rinse, SF, ...show all 63 brand names Use a missed dose as soon as you think about it. Be ready to tell or show what was For Kids. This medicine may cause harm if a large amount is swallowed. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. How to correctly use it since the derections on the tube is n't clear... It since the derections on the tube is n't that clear daily self-topical use as dental., new drug approvals, alerts and updates tell all of the reach of children and pets with am... Be for use in different ages of children help if you have any side effects at https: //www.fda.gov/medwatch health! 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