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Neutramaxx 5000 tcp - Medication Information

Product NDC Code 63783-501
Drug Name

Neutramaxx 5000 tcp

Type Brand
Active Ingredients
Sodium fluoride 1.1 g/112g
Route ORAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 392038,
1191716
Labeler Name Massco Dental A Division of Dunagin Pharmaceuticals
Packages
Package NDC Code Description
63783-501-04 112 g in 1 tube (63783-501-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Section DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient Section Inactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Indications and Usage Section NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

Purpose

Information about the drug product’s indications for use.
Purpose Section For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Spl product data elements

Usually a list of ingredients in a drug product.
NEUTRAMAXX 5000 TCP SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA POLYETHYLENE GLYCOL 8000 CARBOXYMETHYLCELLULOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE TITANIUM DIOXIDE SACCHARIN SODIUM TRIBASIC CALCIUM PHOSPHATE REFRESHING MINT FLAVOR

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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 res Massco__TCP1_label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out of Reach of Children Section As with all medications, keep out of reach of children.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Comments? Section Call 1-479-787-5168 M-F 9am to 5 pm CST

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warning Section Warnings Do not swallow For topical use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API