NDC 63783-500 Neutramaxx 5000 Plus Turbo

Sodium Fluoride

NDC Product Code 63783-500

NDC CODE: 63783-500

Proprietary Name: Neutramaxx 5000 Plus Turbo What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Fluoride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Flavor(s):
MINT (C73404 - MINT FLAVOR)

NDC Code Structure

  • 63783 - Massco Dental A Division Of Dunagin Pharmaceuticals

NDC 63783-500-04

Package Description: 112 g in 1 TUBE

NDC Product Information

Neutramaxx 5000 Plus Turbo with NDC 63783-500 is a a human prescription drug product labeled by Massco Dental A Division Of Dunagin Pharmaceuticals. The generic name of Neutramaxx 5000 Plus Turbo is sodium fluoride. The product's dosage form is paste and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1191716 and 392038.

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Neutramaxx 5000 Plus Turbo Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XYLITOL (UNII: VCQ006KQ1E)
  • POTASSIUM NITRATE (UNII: RU45X2JN0Z)
  • MINT (UNII: FV98Z8GITP)
  • POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Massco Dental A Division Of Dunagin Pharmaceuticals
Labeler Code: 63783
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Fluoride

Fluoride is pronounced as (floor' ide)

Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]

* Please review the disclaimer below.

Neutramaxx 5000 Plus Turbo Product Label Images

Neutramaxx 5000 Plus Turbo Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient Section

DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Inactive Ingredient Section

INACTIVE INGREDIENTS: FILTERED WATER, SORBITAL, HYDRATED SILICA, GLYCERINE, XYLITOL, POTASSIUM NITRATE, MINT FLAVOR, PEG,CARBOXYMETHYLCELLULOSE, TITANIUM DIOXIDE, SODIUM SACCHARIN, DIMETHICONE, POLOXOMER 407

Indications Section

INDICATIONS   NEUTRAMAXXtm 5000 PLUS TURBO IS A SELF-APPLIED DENTIFRICE FOR PREVENTION OF TOOTH DECAY, ORTHODONTIC DECALCIFICATION AND HYPERSENSITIVITY

Warnings Section

DO NOT SWALLOW    FOR TOPICAL USE ONLY    AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREN

Keep Out Of Reach Of Children Section

AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREM

Directions: Use As Directed

THIS PRESCRIPTION DENTIFRICE IS RECOMMENDED FOR ADULTS AND PEDIATRIC PATIENTS 6 YEARS AND OLDER.APPLY A THIN RIBBON OF NEUTRAMAXXtm 500 PLUS TURBO ALONG THE LENGTH OF THE TOOTHBRUSH NO MORE THAN "PEA SIZE" TOTAL DOSE. BRUSH FOR 2 MINUTESAFTER BRUSHING ADULTS-EXPECTORATE; DO NOT EAT OR DRINK FOR 30 MINUTESCHILDREN 6 YEARS OF AGE OR OLDER-EXPECTORATE AND RINSE MOUTH WITH WATERUSE AT BEDTIME IN PLACE OF YOUR REGULAR TOOTHPASTE OR AS DIRECTED BY YOUR DENTAL PROFESSIONAL.

Package Label

PROFESSIONAL CLEANING SYSTEM  NEUTRAMAXXtm 5000 PLUS TURBO  REFRESHING MINT FLAVOR RELIEVES SENSITIVITY1.1% NEUTRAL SODIUM FLUORIDE 5000PPM TOOTHPASTE WITH 5% POTASSIUM NITRATE SWEETENED WITH XYLITOL  DOES NOT CONTAIN SODIUM LAURYL SULFATE  RX ONLY  NET WT. 4 OZ (112 G)  NDC 63783-3233-112 MAUNFACTURES BY: MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE, ar (479) 787-5168  WWW.MASSCODENTAL.NETres

* Please review the disclaimer below.