TruGuard 5000
Generic: SODIUM FLUORIDE TOOTHPASTE
Basic Information
Manufacturer
The Atlanta Dental Supply Company DBA Advanced Dental Products
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
3b8efdcf-5beb-46c2-b118-64940a7fc74b
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.)
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.)
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.
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.
Adverse Reactions
ADVERSE REACTIONS: Allergic reaction and other idiosyncrasies have been rarely reported.