Fluoride Toothpaste
Drug Details
- Generic Name
- Fluoride Toothpaste
- Brand Names
- OraPro Fluoride Anticavity, Salivea, Fluoride
- Application Number
- M021
- Sponsor
- Protegera, Inc.
- NDC Codes
- 4
- Dosage Forms
- PASTE, DENTIFRICE, PASTE
- Routes
- ORAL, DENTAL
- Active Ingredients
- SODIUM FLUORIDE, SODIUM MONOFLUOROPHOSPHATE
Indications and 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.)
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.