NDC 68400-108 Gelato Apf

Sodium Fluoride

NDC Product Code 68400-108

NDC CODE: 68400-108

Proprietary Name: Gelato Apf 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 68400 - Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.

NDC 68400-108-15

Package Description: 454 g in 1 BOTTLE, PLASTIC

NDC Product Information

Gelato Apf with NDC 68400-108 is a a human prescription drug product labeled by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.. The generic name of Gelato Apf is sodium fluoride. The product's dosage form is gel and is administered via dental form.

Labeler Name: Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products 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.

Gelato Apf 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 5.6 g/454g

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • XYLITOL (UNII: VCQ006KQ1E)

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: Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.
Labeler Code: 68400
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: 12-14-2012 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 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’.

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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]

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Gelato Apf Product Label Images

Gelato Apf 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:                                                     Purpose:

Fluoride Ion 1.23% .................................Fluoride Treatment GelAvailable from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Indications And Usage:

  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

Warnings:

  • Keep out of reach of children. Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away. Read directions carefully before using.

Dosage And Administration:

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used a preventative caries treatment two times a year. 1. After thorough propylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth, 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information:

  • Store at controlled room temperature 59° to 86°F (15°-30°C). Protect from freezing.

Inactive Ingredients:

Citric Acid, Flavor, Manesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.

* Please review the disclaimer below.