Neutramaxx 5000 TCP

Dosage Form: paste, dentifrice

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

NEUTRAMAXX 5000 TCP  sodium fluoride  paste, dentifrice

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.1 g  in 112 g

Inactive Ingredients Ingredient Name Strength 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      Shape Size Flavor MINT (REFRESHING MINT FLAVOR) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-501-04 112 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/01/2011

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

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

Establishment
Name	Address	ID/FEI	Operations
Massco Dental A Division of Dunacin Pharmaceuticals		008081858	manufacture

Revised: 11/2011Massco Dental A Division of Dunacin Pharmaceuticals