Active Ingredient Section
DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE
Neutramaxx 5000 Tcp Paste, Dentifrice
FDA Label NDC 63783-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Massco Dental A Division Of Dunagin Pharmaceuticals for the product Neutramaxx 5000 Tcp (NDC 63783-501). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient section, purpose section, keep out of reach of children section, indications and usage section, warning section, directions: use as directed section, inactive ingredient section, questions? comments? section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Massco__tcp1_label (Massco Tcp1 Label)
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