FDA Label for Truguard 5000

Other

TruGuard 5000 1.1% Sodium Fluoride Prescription Toothpaste

Rx Only

Active Ingredients: Sodium Fluoride 1.1%(w/w), Potassium Nitrate

NDC #: 71347-500-04

Description

DESCRIPTION: Self-topical neutral fluoride dentifrice containing 1.1%(w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.

Inactive Ingredient

Inactive Ingredients: Filtered Water, Sorbitol, Hydrated Silica, Glycerin, PEG, Carboxymethylcellulose, Dimethicone, Xylitol, Monosodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin.

Clinical Pharmacology

CLINICAL PHARMACOLOGY: Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolutionand enhance penetration of the fluoride ion into tooth enamel.

Indications & Usage

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 TruGuard brand of 1.1% sodium fluoride in a squeeze tube 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 whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Contraindications

CONTRA INDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Warnings

WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under 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 the cream which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.

Precautions

PRECAUTIONS: Not for systematic treatment. DO NOT SWALLOW.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

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 bodyweight. 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 have 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 (5mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy

Pregnancy: Pregnancy Category B. It has 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 of fetal weight and did not increase the frequency of skeletal or visceral malformations. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects, Heavy exposure to fluoride during utero development may result in skeletal fluorosis, which becomes evident in childhood.

Nursing Mothers

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 product 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 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

Pediatric Use: The use of TruGuard 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 CONTRA INDICATIONS and WARNINGS sections.

Adverse Reactions

ADVERSE REACTIONS: Allergic reaction and other idiosyncrasies have been rarely reported.

Overdosage

OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning of 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 of 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 emesis, 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of TruGuard to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime. 2. After use, adults expectorate. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

Directions: Use As Directed
This prescription dentifrice is
recommended for adults and
pediatric patients 6 years and
older.
• Apply a thin ribbon of TruGuard
  5000 along the length of the
  toothbrush no more than "pea
  size” total dose. Brush for two
  minutes.
• After brushing: ADULTS- Expectorate;
  Expectorate; do not eat or drink
  for 30 minutes. CHILDREN 6
  YEARS OF AGE OR OLDER-Expectorate
  Expectorate and rinse mouth
  with water.
• Use at bedtime in place of your
  regular toothpaste or as
  directed by your dental
  professional.

How Supplied

HOW SUPPLIED: 4 oz. (112 gm) net wt. tube

Other Safety Information

STORAGE: Store at controlled room temperature, 20-25˚C (68-77˚F).

Principal Display Panel - 4 Oz. Tubesodium Fluoride 1.1%(W/W), Potassium Nitrate Toothpaste

Rx Only                                     NDC 71347-500-04

TruGuard 5000

Professional Cleaning Syatem

1.1% Neutral Sodium Fluoride 5000 ppm Toothpaste with 5% Potassium Nitrate. Sweetened with Xylitol. Does not Contain Sodium Lauryl Sulfate.

Net Wt. 4 oz. (112 G)

Distributed by:
Advanced Dental Products
P.O. Box 29279
Atlanta, GA 30359

Carton Label

Tube Label

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