Document
DailyMed Label: TruGuard 5000
Title
DailyMed Label: TruGuard 5000
Date
2023
Document type
DailyMed Prescription
Name
TruGuard 5000
Generic name
Sodium Fluoride Toothpaste
Manufacturer
The Atlanta Dental Supply Company DBA Advanced Dental Products
Product information
NDC: 71347-500
Product information
NDC: 71347-500
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.
Indications
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
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.
Precautions
PRECAUTIONS: Not for systematic treatment. DO NOT SWALLOW.
Adverse reactions
How supplied
HOW SUPPLIED : 4 oz. (112 gm) net wt. tube
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.
Package label
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
res
TruGrd Box-Outer
TruGrd Box-Inner
Tube Label TruGrd
1 organization
1 product
Product
Sodium fluoride