Gelato Apf
Sodium Fluoride
Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.
Human Prescription Drug
NDC 68400-109Gelato Apf also known as Sodium Fluoride is a human prescription drug labeled by 'Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.'. National Drug Code (NDC) number for Gelato Apf is 68400-109. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Gelato Apf drug includes Sodium Fluoride - 5.6 g/454g . The currest status of Gelato Apf drug is Active.
Drug Information:
| Drug NDC: | 68400-109 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Gelato Apf |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM FLUORIDE - 5.6 g/454g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 14 Dec, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 245593
656838
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 8ZYQ1474W7
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68400-109-15 | 454 g in 1 BOTTLE, PLASTIC (68400-109-15) | 01 Jun, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Gelato apf sodium fluoride citric acid monohydrate magnesium aluminum silicate phosphoric acid polysorbate 20 sodium benzoate saccharin sodium titanium dioxide water xanthan gum xylitol fd&c blue no. 1 fd&c green no. 3 fd&c red no. 3 fd&c red no. 40 fd&c yellow no. 5 fd&c yellow no. 6 sodium fluoride fluoride ion
Indications and Usage:
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:
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:
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 as a preventative caries treatment twice a year. 1. after thorough prophylaxis, 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.
Package Label Principal Display Panel:
Lb.gelato apf gel_generic_r2.jpg