Package insert / product label
Generic name: sodium fluoride and potassium nitrate gel
Dosage form: gel, dentifrice
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.
On This Page
- Description
- Clinical Pharmacology
- Indications and Usage
- Contraindications
- Warnings
- Precautions
- Adverse Reactions/Side Effects
- Overdosage
- Dosage and Administration
- How Supplied/Storage and Handling
- References
Expand
SENSITIVE
Rx ONLY
1.1% Sodium Fluoride, 5% Potassium Nitrate
Prescription Strength Toothpaste for Sensitive Teeth
Prevident 5000 Sensitive Description
Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.
Active Ingredients
Sodium fluoride 1.1% (w/w), Potassium nitrate 5%
Inactive Ingredients
water, hydrated silica, sorbitol, PEG-12, carrageenan, sodium lauryl sulfate, flavor, poloxamer 407, cocamidopropyl betaine, sodium saccharin, mica, sodium hydroxide, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1
Prevident 5000 Sensitive - Clinical Pharmacology
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.
Indications and Usage for Prevident 5000 Sensitive
A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. 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 PreviDent® 5000 Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Contraindications
Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
Warnings
Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Precautions
General
Not for systemic treatment. DO NOT SWALLOW.
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. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 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. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. 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. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. 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. 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.
Pregnancy
Teratogenic Effects
Pregnancy Category B
It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. 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. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
Nursing Mothers
It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. 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). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
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. 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. 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. 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
Adverse Reactions
Allergic reactions and other idiosyncrasies have been rarely reported.
Overdosage
Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. 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. 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. 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.
A treatment dose (a thin ribbon) of PreviDent® 5000 Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.
Prevident 5000 Sensitive Dosage and Administration
Follow these instructions unless otherwise instructed by your dental professional:
- Adults and children 12 years of age and older: Apply at least 1 inch strip of PreviDent® 5000 Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly.
- Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician.
How is Prevident 5000 Sensitive Supplied
3.4 FL OZ (100 mL) in plastic bottles. Mild Mint: NDC 0126-0070-61
STORAGE
Store at Controlled Room Temperature, 68-77°F (20-25°C)
REFERENCES
- American Dental Association, Accepted Dental Therapeutics Ed. 40 (Chicago, 1984): 405-407.
- H.R. Englander et al., JADA 75 (1967): 638-644.
- H.R. Englander et al., JADA 78 (1969): 783-787.
- H.R. Englander et al., JADA 83 (1971): 354-358.
- Data on file, Colgate Oral Pharmaceuticals.
Questions? Comments? Please Call 1-800-962-2345
www.colgateprofessional.com
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
P9931140
NDC 0126-0070-61
Colgate®
PreviDent®
5000 ppm
Rx Only
SENSITIVE
1.1%
Sodium
Fluoride
5%
Potassium
Nitrate
PRESCRIPTION STRENGTH
TOOTHPASTE
for SENSITIVE TEETH
mild mint
3.4 FL OZ (100 mL)
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Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)
Colgate Oral Pharmaceuticals, Inc.
Medical Disclaimer
FAQs
Is Prevident 5000 covered by insurance? ›
Medicare Part D and Medicare Advantage prescription drug insurance plans usually do not cover Prevident 5000 Plus. Instead, Prevident 5000 Plus is typically covered by dental insurance and often is supplied by a dentist, who purchases Prevident 5000 Plus from specialty pharmacies.
Do I need a prescription for Prevident 5000? ›Colgate PreviDent 5000 Booster Plus is a prescription-only toothpaste containing 1.1% sodium fluoride (5000 ppm fluoride) available in the US.
What does Prevident 5000 do for your teeth? ›This medication is used to prevent cavities and to reduce pain from sensitive teeth (dentinal hypersensitivity). Sodium fluoride works by making the teeth stronger and more resistant to decay caused by acid and bacteria.
Why do people get prescribed Prevident? ›Prevident is used to help prevent cavities, tooth decay, and gum disease. This medicine can also help strengthen tooth enamel, remove plaque bacteria from teeth and gums, and decrease painful tooth sensitivity. Fluoride may also be used for purposes not listed in this medication guide.
Can you leave PreviDent on your teeth? ›Use this medication once daily just before bedtime or as directed by your doctor/dentist. First brush your teeth thoroughly with toothpaste, and rinse as usual. Then apply a thin ribbon of this medication to your teeth with a toothbrush or mouth tray. Leave the medication on for at least 1 minute.
What is the generic equivalent of PreviDent 5000? ›SODIUM FLUORIDE ENAMEL PROTECT (Generic for PREVIDENT 5000 SENSITIVE)
What is the difference between Prevident and regular toothpaste? ›While OTC toothpaste typically contains from 1,000 to 1,500 parts per million of fluoride, prescription fluoride toothpaste will contain a much higher concentration. Dentists will prescribe prescription fluoride toothpaste, like Colgate's PreviDent, to help their patients avoid cavities.
Do you use Prevident instead of toothpaste? ›How to use Prevident 5000 Plus Cream. This is best used once daily just before bedtime instead of your regular toothpaste or as directed by your healthcare professional. Apply a thin ribbon of medicine to a toothbrush and brush thoroughly for 2 minutes or as directed. Spit out the medication after use.
How long does it take for Prevident to work? ›How long does it take Prevident to work? Prevident products can work quickly to improve dental health. Early tooth decay can reverse within 3 months of using Prevident 5000 products. This is most likely near the root surface.
Do you rinse after brushing with PreviDent? ›Make sure that you spit out the medicine after each use—do not swallow. Additionally, avoid eating, rinsing your mouth, or drinking for at least 30 minutes after brushing for the best results.
What are the side effects of using PreviDent? ›
- Black, tarry stools.
- bloody vomit.
- diarrhea.
- drowsiness.
- faintness.
- increased watering of the mouth.
- nausea or vomiting.
- shallow breathing.
PreviDent
Sodium fluoride has been shown to strengthen teeth and prevent tooth decay and weakened enamel that is primarily caused by bacteria and acid.
- Colgate Total. ...
- Crest Pro-Health. ...
- Sensodyne ProNamel Gentle Whitening Toothpaste. ...
- Arm and Hammer Dental Care Advance Cleaning Mint Toothpaste w/Baking Soda. ...
- Tom's of Maine Natural Anticavity Fluoride Toothpaste. ...
- Crest Tartar Protection. ...
- Tom's of Maine Simply White Clean Mint Toothpaste.
PreviDent® 5000 Dry Mouth (Rx) brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional.
Can prescription fluoride toothpaste side effects? ›What side effects may I notice from receiving this medication? Side effects that you should report to your care team as soon as possible: Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat. Change in tooth color.
What happens if you swallow Prevident toothpaste? ›Acute burning in the mouth and sore tongue may be experienced by some individuals. If accidental ingestion occurs, side effects may include nausea, vomiting, diarrhea, and abdominal pain.
Can Prevident dry your mouth? ›Prevident 5000 Dry Mouth does not contain sodium lauryl sulfate which dries out the mouth.
Which OTC toothpaste has the most fluoride? ›Which Toothpastes Have The Highest Fluoride Content? Colgate® PreviDent® 5000 Booster Plus (1.1% Sodium Fluoride) Prescription Strength Toothpaste is among the highest fluoridated toothpastes available.
Does CVS have PreviDent? ›If you do not have health insurance, you can use our Prevident 5000 Enamel Protect coupons for instant savings on this prescription drug at participating pharmacies like CVS, Walmart, Kroger, or Walgreens.
Why do you have to have a prescription for Colgate PreviDent? ›The reason that a prescription is required is due to the high amounts of fluoride in the toothpaste and in the wrong hands that can be dangerous like children. There are many brands and types of prescription toothpaste for example PreviDent, Fluoridex, Clinpro 5000 and GC MI Paste just to name a few.
Which is the best medicated toothpaste? ›
- Quip Mint Anticavity Toothpaste.
- Arm & Hammer Dental Care Toothpaste.
- PRO-SYS Mint Fluoride Toothpaste Gel.
- Parodontax Clean Mint Daily Fluoride Toothpaste.
- SprinJene Fresh Boost Fluoride Toothpaste.
- CloSYS Fluoride Toothpaste.
- Sensodyne Toothpaste.
- AloeSense Toothpaste.
#2- Desensitizing Toothpaste: Sensodyne toothpaste, MI Paste, and PreviDent are created specifically for remineralization of the tooth but also help with sensitivity. Sensodyne is available over the counter while MI Paste and PreviDent are stronger strength and can be dispensed at our dental office.
Why is high fluoride toothpaste prescription only? ›Why do you need a prescription for high fluoride toothpaste? Toothpastes with high amounts of fluoride are only available on prescription from your dentist or a private pharmacy. This is because it has a much higher concentration of fluoride than standard toothpaste, which isn't suitable for everyone.
Should you rinse prescription toothpaste? ›Once finished brushing - spit, do not rinse, drink or eat anything prior to going to bed. This allows the fluoride to sit on the teeth longer and strengthen the teeth as you sleep. This product can also be used to treat sensitive teeth with the same directions as above.
Can you use PreviDent long term? ›"Because it is a prescription toothpaste, it has more clinical weight with patients, and they therefore are more likely to use it," she observes. In her experience, Calderbank has noticed that long-term use of PreviDent 5000 results in stronger teeth, as well as the retardation of cervical and root caries.
Can I use PreviDent forever? ›Answer: Teeth sensitivity
Using these two together is not a problem, and can be used indefinitely.
When Can I brush my Teeth after Fluoride Treatment? A dentist near you will advise you to wait between 4-and 6 hours before resuming your brushing and flossing routine. One should therefore wait for six hours before resuming the oral care routine.
Can you drink water after using prescription fluoride toothpaste? ›For maximum fluoride efficacy, patients should not be permitted to rinse, eat, or drink for 30 min following the topical application of fluoride.
Can you use Prevident in the morning? ›Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
What are the side effects of just right 5000 toothpaste? ›A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects.
What is the fastest way to rebuild tooth enamel? ›
Use fluoride treatment
Fluoride is tooth enamel's best friend, helping to strengthen and restore it after normal wear and tear. The best way to implement fluoride treatment while working to restore tooth enamel is to use a fluoride-based toothpaste and mouthwash.
- Sensodyne. The best part about Sensodyne toothpaste is that it comes in an array of different toothpaste options and capabilities. ...
- Colgate Sensitive. ...
- hello sensitivity relief fluoride toothpaste. ...
- Tom's of Maine Rapid Relief Sensitive. ...
- Squigle Tooth Builder Sensitive Toothpaste.
Today, Colgate is the most recognized name in toothpaste in the United States. Colgate toothpaste was reformulated in 1968 to include fluoride as a way of maintaining oral health.
What is the number one selling toothpaste? ›...
Sales of the leading toothpaste brands in the United States in 2019 (in million U.S. dollars)*
Dental hygienists use a flavored polishing toothpaste made of pumice, flavoring, and usually a tiny amount of fluoride. This normally follows the scaling process, which is when hygienists use metal tools to scrape plaque and tartar from your teeth. The polishing toothpaste is much more coarse than regular toothpaste.
What are the side effects of sensitive toothpaste? ›It is commonly used for the diagnosis or treatment of Tooth relief, mnty taste, cavity protection, freshens breath, stops sensitivity. It has some side effects such as Oral discomfort, swollen tongue, oral pain, swollen tongue.
What negative effects does fluoride have on the body? ›Fluoride intake has both beneficial effects – in reducing the incidence of dental caries – and negative effects – in causing tooth enamel and skeletal fluorosis following prolonged high exposure. The ranges of intakes producing these opposing effects are not far apart.
What are the symptoms of too much fluoride? ›- Abdominal pain.
- Abnormal taste in the mouth (salty or soapy taste)
- Diarrhea.
- Drooling.
- Eye irritation (if it gets in the eyes)
- Headache.
- Abnormal levels of calcium and potassium in the blood.
- Irregular or slow heartbeat.
Dental plans usually cover fluoride treatments for children but not for adults.
Is fluoride covered by dental insurance? ›Most dental insurance providers, including Medicaid and Child Health Plus, cover fluoride varnish application.
Is there a generic for PreviDent 5000 plus? ›
Yes, there are generic toothpastes for PreviDent 5000 Plus. They are called Denta 5000 Plus or SF 5000 Plus.
Is sodium fluoride covered by insurance? ›No. In general, Medicare prescription drug plans (Part D) do not cover this drug. Be sure to contact your specific plan to verify coverage information. A limited set of drugs administered in a doctor's office or hospital outpatient setting may be covered under Medical Insurance (Part B).
Should seniors get fluoride treatments? ›There are several reasons fluoride treatments could be beneficial to you as a grownup. If you have a high risk for cavities, topical fluoride applications can cut down on that risk. If you're experiencing gum recession that's softening your enamel, fluoride treatments can slow down that process.
Can Prevident reverse cavities? ›Prevident products can benefit your dental health. They are useful in preventing or reversing early cavities. If you have certain dental health needs, you can still use Prevident.
Is fluoride treatment at the dentist worth the money? ›Many adults wonder, “Are fluoride treatments beneficial for adults?” The answer is yes. All adults can benefit from a dental fluoride treatment, especially those at a higher risk for tooth decay. Insurance doesn't normally cover fluoride for adults, but the price is usually only around $20-40—well worth the extra cost.
What age do you stop fluoride treatments? ›Generally, these treatments end around age 14, but some people continue to get them into adulthood.
How much does a tube of fluoride cost? ›A fluoride rinse after your dental cleaning probably won't have a fee attached to it but if you need a separate fluoride treatment, you can expect to pay between $20 and $50. Fluoride treatments are considered preventative so your dental insurance may cover a large portion or all of the cost.
Do you use PreviDent instead of toothpaste? ›How to use Prevident 5000 Plus Cream. This is best used once daily just before bedtime instead of your regular toothpaste or as directed by your healthcare professional. Apply a thin ribbon of medicine to a toothbrush and brush thoroughly for 2 minutes or as directed. Spit out the medication after use.
How many times a day should I use PreviDent? ›PreviDent® 5000 Dry Mouth (Rx) brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional.
Why did my dentist give me sodium fluoride? ›SODIUM FLUORIDE (SOE dee um FLOOR ide) paste is used to prevent tooth decay. It also helps to decrease sensitivity of the teeth. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
How much does prescription fluoride cost? ›
The approximate retail price of Sodium Fluoride is usually around $19.33. Use a SingleCare Sodium Fluoride coupon to reduce your cost for Sodium Fluoride down to $3.10. SingleCare coupons are completely free and can be found online and on the mobile app for most prescription drugs.
How often should you use prescription fluoride? ›The use of prescription fluoride toothpaste can reduce these cavities by 70% and even reverse decay in over half of the affected teeth. Prescription strength fluoride toothpaste should be used once daily in place of your regular toothpaste.