Fluoride Toothpaste

FDA Drug Profile — OraPro Fluoride Anticavity, Salivea, Fluoride

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.