Your browser does not support JavaScript! NEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]
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NEUTRAMAXX 5000 TCP (sodium fluoride) paste, dentifrice
[Massco Dental A Division of Dunagin Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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

NeutraMax 5000 TCP Label

NEUTRAMAXX 5000 TCP 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63783-501
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE1.1 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 8000 
CARBOXYMETHYLCELLULOSE 
XYLITOL 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
TITANIUM DIOXIDE 
SACCHARIN SODIUM DIHYDRATE 
TRIBASIC CALCIUM PHOSPHATE 
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/01/2011
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

Revised: 2/2012
 
Massco Dental A Division of Dunagin Pharmaceuticals

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