60 Second Taste Bubblegum
Topical Apf Fluoride Gel
Pascal Company, Inc.
Human Prescription Drug
NDC 10866-018560 Second Taste Bubblegum also known as Topical Apf Fluoride Gel is a human prescription drug labeled by 'Pascal Company, Inc.'. National Drug Code (NDC) number for 60 Second Taste Bubblegum is 10866-0185. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in 60 Second Taste Bubblegum drug includes Sodium Fluoride - 12.3 mg/g . The currest status of 60 Second Taste Bubblegum drug is Active.
Drug Information:
| Drug NDC: | 10866-0185 |
| 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: | 60 Second Taste Bubblegum |
| 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: | Topical Apf Fluoride Gel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pascal Company, 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 - 12.3 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | BUCCAL
DENTAL
TOPICAL
|
| 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 Apr, 1988 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 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: | Pascal Company, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 10866-0185-2 | 480 g in 1 BOTTLE, PLASTIC (10866-0185-2) | 01 Apr, 1988 | 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:
60 second taste bubblegum topical apf fluoride gel sodium fluoride fluoride ion
Indications and Usage:
Indications for use professionally applied dental caries preventive
Warnings and Cautions:
Warnings and precautions keep out or reach of children. for topical intraoral use only. for professionally applied, in office fluoride treatment only. not for system treatment. do no swallow. do not use on patients with an allergy to fluoride. 60 second taste contains artificial color and flavor; confirm that no known patient allergies exist. marshmallow and chocolate vanilla are dye free and contain no aritifical colors. special care should be used when administering to children under 6 years of age so that gel is not swallowed. contact with abraided or sensitive oral tissue may produce discomfort. if more than in ordinarily used for treatment is swallowed, administer calcium such as milk and contact your local poison control center immediately.
Dosage and Administration:
Dosage and directions for use usual dosage is approximately 2.75 - 9 grams of 60 second taste per dual arch treatment depending on tray size. shake well before use after prophylaxis remove excess fluid from teeth. fill applicator tray 1/3 full with gel. insert filled tray into patient's mouth and instruct to bite down gently for one minute, or up to four minutes. after treatment time is completed, remove tray and have patient expectorate residual gel. for maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes. repeat treatment at least once or twice a year. for patients with rampant or active caries, repeat treatment once or twice every six months. if contents have become frozen, warm to room temperature and shake well before using.
Contraindications:
Contraindications contraindicated in individuals who are hypersensitive to fluoride.
Package Label Principal Display Panel:
60 second taste gel anticavity topical apf* preventive treatment gel *acidulated phosphate fluoride bubblegum 60 second taste bottle flavor label