FDA Label for Neutramaxx 5000 Tcp

View Indications, Usage & Precautions

Neutramaxx 5000 Tcp Product Label

The following document was submitted to the FDA by the labeler of this product Massco Dental A Division Of Dunagin Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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