NEUTRAMAXX 5000 TCP- sodium fluoride paste, dentifrice 
Massco Dental A Division of Dunagin Pharmaceuticals

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

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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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NEUTRAMAXX 5000 TCP 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINT (REFRESHING MINT FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-501-04112 g in 1 TUBE; Type 0: Not a Combination Product08/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2011
Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Establishment
NameAddressID/FEIBusiness Operations
Massco Dental A Division of Dunagin Pharmaceuticals008081858manufacture(63783-501)

Revised: 12/2023
Document Id: 22fb5942-a2d6-4f0e-8064-a6012e05f43b
Set id: f47cb584-eb8a-4297-ba32-5f435e85aacb
Version: 7
Effective Time: 20231217
 
Massco Dental A Division of Dunagin Pharmaceuticals