NDC 0126-0022 Prevident 5000 Enamel Protect

Sodium Fluoride And Potassium Nitrate

NDC Product Code 0126-0022

NDC CODE: 0126-0022

Proprietary Name: Prevident 5000 Enamel Protect What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Fluoride And Potassium Nitrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

NDC 0126-0022-12

Package Description: 3.5 mL in 1 PACKET

NDC 0126-0022-92

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Prevident 5000 Enamel Protect with NDC 0126-0022 is a a human prescription drug product labeled by Colgate Oral Pharmaceuticals, Inc.. The generic name of Prevident 5000 Enamel Protect is sodium fluoride and potassium nitrate. The product's dosage form is gel, dentifrice and is administered via dental form.

Labeler Name: Colgate Oral Pharmaceuticals, Inc.

Dosage Form: Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Prevident 5000 Enamel Protect Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM FLUORIDE 5.8 mg/mL
  • POTASSIUM NITRATE 57.5 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.
  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Colgate Oral Pharmaceuticals, Inc.
Labeler Code: 0126
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-30-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Prevident 5000 Enamel Protect Product Label Images

Prevident 5000 Enamel Protect Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx ONLY1.1% Sodium Fluoride, 5% Potassium NitratePrescription Strength Toothpaste For Sensitive Teeth

Questions? Comments? Please Call: 1-800-962-2345 www.colgateprofessional.com

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, titanium dioxide, cocamidopropyl betaine, sodium saccharin, sodium hydroxide

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

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 Enamel Protect 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.

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 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 Enamel Protect contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.

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 a 1 inch strip of PreviDent® 5000 Enamel Protect 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 Supplied

3.4 FL OZ (100 mL) in plastic bottles. Mint: NDC 0126-0022-92

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.

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