Neutramaxx 5000 TCP

Generic name:sodium fluoride
Dosage form: oral paste, dentifrice
Drug class:Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Dec 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Drug Facts
Active Ingredients

1.1 % Neutral Sodium Floride

DESCRIPTION:

Self-topical neutral fluoride dentifrice containing 1.1%(w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.

Purpose

For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Keep Out of Reach of Children.

As with all medications, keep out of reach of children.

CLINICAL PHARMACOLOGY:

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increases tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

INDICATIONS AND USAGE:

NeutraMaxx™ 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

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 NeutalMaxx™ 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 fluorisis. (See WARNINGS for exceptions)

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 preform the brushing process without significant swallowing. Use in pediatric patients under 6 years requires special supervision to prevent repeated swallowing of the cream which could cause dental fluorosis. Read directions carefully before using. Keep out o..