Label: PREVIDENT 5000 PLUS SPEARMINT- sodium fluoride paste, dentifrice
- NDC Code(s): 0126-0287-33
- Packager: Colgate Oral Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- SPL UNCLASSIFIED SECTION
1.1% Sodium Fluoride
PRESCRIPTION STRENGTH TOOTHPASTE
Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.Close
- Active Ingredient
Sodium fluoride 1.1% (w/w).Close
- Inactive Ingredients
water, sorbitol, hydrated silica, PEG-12, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor, xanthan gum, sodium benzoate, sodium saccharin, FD&C blue no. 1.Close
- 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.Close
- INDICATIONS AND USAGE
A dental caries preventive, for once daily self-applied topical use. 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 Plus brand of 1.1% sodium fluoride in a squeezetube is easily applied onto a toothbrush. This prescription dental cream should be used once 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).Close
Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.Close
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. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.Close
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.
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.
The use of PreviDent® 5000 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 11-14 years conducted by Englander, et al. 2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
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.
- ADVERSE REACTIONS
Allergic reactions and other idiosyncrasies have been rarely reported.Close
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 Plus contains approximately 2.5 mg fluoride. A 1.8 oz. tube contains approximately 255 mg fluoride.Close
- DOSAGE AND ADMINISTRATION
Follow these instructions unless otherwise instructed by your dental professional:
- Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Plus to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime.
- After use, adults expectorate. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, ages 6-16 years, expectorate after use and rinse mouth thoroughly.
- HOW SUPPLIED
Spearmint Fruitastic™ 1.8 oz. (51 g) net wt. plastic tubes. NDC 0126-0287-66 NDC 0126-0286-66 Twin Pack (two 1.8 oz. (51 g) net wt. tubes) NDC 0126-0287-33
- American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407 (1984).
- H.R. Englander et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 75, 638-644 (1967).
- H.R. Englander et al., Residual Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 78, 783-787 (1969).
- Englander HR, et al: JADA 83:354-358, 1971.
- SPL UNCLASSIFIED SECTION
Fruitastic is a licensed trademark of National Fruit Products Co. Inc.
Colgate Oral Pharmaceuticals, Inc.
a subsidiary of Colgate-Palmolive Company
New York, NY 10022 U.S.A.
Questions or Comments: 1-800-962-2345
Rev. June 2009Close
- PRINCIPAL DISPLAY PANEL - 51 g Tube Carton
1.1% Sodium Fluoride
PRESCRIPTION STRENGTH TOOTHPASTE
Two - 1.8 OZ (51 g) tubes - Total NET WT. 3.6 OZ (102 g)
- INGREDIENTS AND APPEARANCE
PREVIDENT 5000 PLUS SPEARMINT
sodium fluoride paste, dentifrice
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0126-0287 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 11 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Potassium Pyrophosphate (UNII: B9W4019H5G) Polyethylene Glycols (UNII: 3WJQ0SDW1A) Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY) Xanthan Gum (UNII: TTV12P4NEE) FD&C Blue No. 1 (UNII: H3R47K3TBD) Sodium Benzoate (UNII: OJ245FE5EU) Sorbitol (UNII: 506T60A25R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Sodium Lauryl Sulfate (UNII: 368GB5141J) Product Characteristics Color BLUE (viscous) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0126-0287-33 2 in 1 CARTON 1 53.2 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 08/29/2012 Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)