Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED : 4 oz. (112 gm) net wt. tube; PRINCIPAL DISPLAY PANEL - 4 OZ. Tube Sodium 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 res TruGrd Box-Outer TruGrd Box-Inner Tube Label TruGrd
- HOW SUPPLIED : 4 oz. (112 gm) net wt. tube
- PRINCIPAL DISPLAY PANEL - 4 OZ. Tube Sodium 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 res TruGrd Box-Outer TruGrd Box-Inner Tube Label TruGrd
Overview
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 & 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 & 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.
Warnings & Precautions
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.
Contraindications
CONTRA INDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Adverse Reactions
Allergic reaction and other idiosyncrasies have been rarely reported.
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