NDC 43498-301 Burkhart Neutral

Sodium Fluoride

NDC Product Code 43498-301

NDC Product Information

Burkhart Neutral with NDC 43498-301 is a a human prescription drug product labeled by Burkhart Dental Supply Inc. The generic name of Burkhart Neutral is sodium fluoride. The product's dosage form is gel and is administered via dental form.

Labeler Name: Burkhart Dental Supply Inc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Burkhart Neutral 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.

  • SODIUM FLUORIDE .597 g/120g

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.

  • CASEIN (UNII: 48268V50D5)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

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

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Burkhart Dental Supply Inc
Labeler Code: 43498
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: 02-11-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients


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.

Burkhart Neutral 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:

1.1% Sodium Fluoride.


Aids in prevention of dental caries and hypersensitivity. Use as directed by your dentist.


Do not swallow. To avoid ingestion, supervision is required while children are using the product. Keep out of reach of children.


  • Adults and children 6 years of age and older: Twist off cap to remove foil seal.Use once daily after brushing teeth thoroughly with toothpaste.Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces for at least 1 minute.Expectorate, do not swallow, do not eat, drink or rinse for at least 30 minutes.Children under 6 years of age:Consult a dentist or physcian.

Storage And Handling

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Inactive Ingredients:

Calcium Caseinate, Citric Acid, Flavor, Glycerine, Glydant, Sodium Benzoate, Sodium Hexameta Phosphate, Sodium Saccharine, TriCalcium Phosphate, Vitamin E, Water, Xanthan Gum, Xylitol.

* Please review the disclaimer below.

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