NEUTRAMAXX 5000 TCP- sodium fluoride paste, dentifrice

NEUTRAMAXX 5000 TCP by

Drug Labeling and Warnings

NEUTRAMAXX 5000 TCP by is a Prescription medication manufactured, distributed, or labeled by Massco Dental A Division of Dunagin Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient Section

DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Purpose Section

For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Keep Out of Reach of Children Section

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

Indications and Usage Section

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

Warning Section

Warnings  Do not swallow   For topical use only  

Directions: Use As Directed Section

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.   Use at bedtime in place of your regular toothpaste or as directed by your dental professional.

Inactive Ingredient Section

Inactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate

Questions? Comments? Section

Call 1-479-787-5168  M-F 9am to 5 pm CST

Package Label

REFRESHING MINT FLAVOR RELIEVES SENSITIVITY

ANTI-CAVITY TOOTHPASTE  NeutraMaxx tm 5000 TCP  XYLITO1.1% 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, Gravette, AR  (479) 787-5168  www.masscodental.net

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INGREDIENTS AND APPEARANCE

NEUTRAMAXX 5000 TCP 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63783-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (REFRESHING MINT FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63783-501-04	112 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2011

Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)

Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)

Establishment
Name	Address	ID/FEI	Business Operations
Massco Dental A Division of Dunagin Pharmaceuticals		008081858	manufacture(63783-501)