Document

DailyMed Label: NEUTRAMAXX 5000 TCP

Title
DailyMed Label: NEUTRAMAXX 5000
Date
2023
Document type
DailyMed Prescription
Name
NEUTRAMAXX 5000
Generic name
SODIUM FLUORIDE
Manufacturer
Massco Dental A Division of Dunagin Pharmaceuticals
Product information
NDC: 63783-502
Product information
NDC: 63783-502
Product information
NDC: 63783-502
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.
Indications
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)
Dosage
This prescription dentifrice is recommended for adults and pediatric patients 6 years and older Apply a thin ribbon of NeutraMaxxtm  5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes. After brushing  ADULTS - Expectorate, do not eat for 30 minutes.   CHILDREN 6 YEARS OF AGE OR OLDER - Expectorate and rinse mouth with water.   Rinse mouth thoroughly. Use at bedtime in place of your regular toothpaste or as directed by your dental professional. Follow these instructions unless otherwise instructed by you dental professional.
Precautions
Not for systemic treatment. DO NOT SWALLOW.
Adverse reactions
Allergic reaction and other idosyncrasies have been rarely reported.
How supplied
4 oz. (112 gm) net wt. tube
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.
Package label
NDS 63783 63783-502-04 VANILLA MINT FLAVOR ANTI-CAVITY TOOTHPASTE       XYLITOL NeutraMaxx™ 5000 TRI-CALCIUM PHOSPHATE 1.1% Neutral Sodium Fluoride 5000 ppm Sweetened with Xylitol DOES NOT CONTAIN SODIUM LAURYL SULFATE RX ONLY Net wt. 4 oz (112 G) Manufactured By: MASSCO DENTAL A Division of Dunagin Pharmaceuticals, Rogers, AR 800-227-1296 • www.masscodental.net MasscoNeutraMaxTCP 502-1.jpg MasscoNeutraMaxTCP 502-2.jpg

1 organization

1 product