Drugplain

TruGuard 5000 5 g/100g

Sodium Fluoride Toothpaste · PASTE, DENTIFRICE · The Atlanta Dental Supply Company DBA Advanced Dental Products

No Recall HistoryCurrently in Shortage
Plain English

TruGuard 5000 is a paste, dentifrice containing sodium fluoride toothpaste at 5 g/100g, taken oral. Manufactured by The Atlanta Dental Supply Company DBA Advanced Dental Products.

Key Facts

Brand Name
TruGuard 5000
Generic Name
Sodium Fluoride Toothpaste
NDC Code (Product)
71347-500
Manufacturer
The Atlanta Dental Supply Company DBA Advanced Dental Products
Strength
5 g/100g
Dosage Form
PASTE, DENTIFRICE
Route
ORAL
Marketing Status
Marketing Start
03/16/2023

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.)

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.

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.

Contraindications

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

Adverse Reactions

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

Frequently Asked Questions

What is TruGuard 5000 used for?

TruGuard 5000 contains Sodium Fluoride Toothpaste. It is a paste, dentifrice taken oral. Consult your doctor for specific uses.

Is TruGuard 5000 a controlled substance?

TruGuard 5000 is not classified as a controlled substance by the DEA.

What is the generic name for TruGuard 5000?

The generic name for TruGuard 5000 is Sodium Fluoride Toothpaste. There are no other listed brand versions of Sodium Fluoride Toothpaste.

What is the NDC code for TruGuard 5000 5 g/100g?

The NDC (National Drug Code) for TruGuard 5000 5 g/100g is 71347-500, listed by The Atlanta Dental Supply Company DBA Advanced Dental Products.

Product NDC

71347-500

Package NDC

71347-500-04

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)