TruGuard 5000
Sodium Fluoride Toothpaste · Paste, Dentifrice · Oral
Uses
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.)
Dosage and 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.
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.
Side effects
ADVERSE REACTIONS: Allergic reaction and other idiosyncrasies have been rarely reported.
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.
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.
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.
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.
How supplied
HOW SUPPLIED : 4 oz. (112 gm) net wt. tube
Label text from the FDA structured product label by The Atlanta Dental Supply Company DBA Advanced Dental Products (revised Dec 28, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride in 1 product
- Potassium Nitrate in 1 product
TruGuard 5000 NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 71347-500 | Sodium Fluoride 1.1 g/100g; Potassium Nitrate 5 g/100g Paste, Dentifrice | The Atlanta Dental Supply Company DBA Advanced Dental Products | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is TruGuard 5000 used for?
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…
What are the side effects of TruGuard 5000?
ADVERSE REACTIONS: Allergic reaction and other idiosyncrasies have been rarely reported. See the full label for the complete list.
Who makes TruGuard 5000?
TruGuard 5000 is listed by 1 labeler in the FDA NDC directory, including The Atlanta Dental Supply Company DBA Advanced Dental Products.