Denti-care Denti-pro Topical Sodium Fluoride 60 Second
Sodium Fluoride
Amd Medicom Inc.
Human Prescription Drug
NDC 64778-0216Denti-care Denti-pro Topical Sodium Fluoride 60 Second also known as Sodium Fluoride is a human prescription drug labeled by 'Amd Medicom Inc.'. National Drug Code (NDC) number for Denti-care Denti-pro Topical Sodium Fluoride 60 Second is 64778-0216. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Denti-care Denti-pro Topical Sodium Fluoride 60 Second drug includes Sodium Fluoride - .0272 g/mL . The currest status of Denti-care Denti-pro Topical Sodium Fluoride 60 Second drug is Active.
Drug Information:
| Drug NDC: | 64778-0216 |
| 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: | Denti-care Denti-pro Topical Sodium Fluoride 60 Second |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Denti-care Denti-pro |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Topical Sodium Fluoride 60 Second |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Amd Medicom 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 - .0272 g/mL
|
| 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: | 01 Oct, 1999 |
| 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: | AMD Medicom Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1535362
1535364
|
| 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 |
|---|
| 64778-0216-3 | 12 BOTTLE, PLASTIC in 1 CASE (64778-0216-3) / 480 mL in 1 BOTTLE, PLASTIC (64778-0216-1) | 01 Dec, 2017 | 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:
Denti-care denti-pro topical sodium fluoride 60 second sodium fluoride sodium fluoride fluoride ion
Indications and Usage:
Indications and directions indications: topical anti-carie preparation directions: following prophylaxis treatment, fill 1/3 of tray with gel insert tray in the patient's mouth have patient bite down lightly for 60 seconds remove tray and have patient expectorate excess advise patient not to eat, drink or rinse for 30 minutes after the application medicinal ingredients: fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
Warnings and Cautions:
Warnings keep out of reach of children. for professional use only. not recommended for use by children under 18 months of age. store at room temperature. do not expose to excessive heat over 40ºc or 104ºf. do not use if seal is broken.
Description:
General information amd medicom inc. denticare pro-gel 2.72% topical sodium fluoride gel 60 second application (1.23% fluoride ions) mint 16.23 fl oz / 480ml ndc 64778-0216-1 npn 80008336 rx only us item code 10021-m
Package Label Principal Display Panel:
Principal display panel panel 1