Zooby Gator Gum
Sodium Fluoride
Young Dental Manufacturing Co 1, Llc
Human Prescription Drug
NDC 0273-0370Zooby Gator Gum also known as Sodium Fluoride is a human prescription drug labeled by 'Young Dental Manufacturing Co 1, Llc'. National Drug Code (NDC) number for Zooby Gator Gum is 0273-0370. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Zooby Gator Gum drug includes Sodium Fluoride - 2.72 g/100g . The currest status of Zooby Gator Gum drug is Active.
Drug Information:
| Drug NDC: | 0273-0370 |
| 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: | Zooby Gator Gum |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Zooby |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Gator Gum |
| 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: | Young Dental Manufacturing Co 1, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Foam |
| 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 - 2.72 g/100g
|
| 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 Aug, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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, 2024 |
| 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: | Young Dental Manufacturing Co 1, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 248389
1193240
|
| 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 |
|---|
| 0273-0370-44 | 125 g in 1 CAN (0273-0370-44) | 01 Aug, 2010 | 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:
Zooby gator gum sodium fluoride sodium fluoride fluoride ion
Indications and Usage:
Indications for the topical application of fluoride to aid in the protection against dental caries. optimized low ph for a 1 minute fluoride treatments.
Warnings and Cautions:
Warnings do not spray toward open flame. contents under pressure. do not puncture or incinerate. keep out of reach of children. store between 59-86º f (15-30º c). keep from freezing. refer to material safety data sheet for additional information. for emergencies contact infotrac at 1-800-535-5053
Dosage and Administration:
Dosage and administration 1. break protective tab adjacent to trigger. 2. shake can thoroughly for at least 15 seconds before each use. 3. hold can completely upside down to dispense and fill fluoride tray by slowly depressing the nozzle. (the foam will expand slightly higher than the fluoride tray.) 4. dry tooth surfaces prior to inserting tray(s) in mouth. 5. insert tray(s) into patientâs mouth and have them bite down for 1-4 minutes. 6. remove tray(s) and have patient expectorate. 7. advise the patient not to eat, drink or rinse for 30 minutes after the treatment.
Description:
Description product name- zooby, 1.23 % apf foam (gator gum flavor) distributed by - denticator earth city, mo 63045. net weight - 4.4 oz (125g) rx only zooby, 1.23 % apf foam (gator gum flavor) contains 1.23 % fluoride ion from 2.72 % sodium fluoride.does not contain chlorofluorocarbon propellant. gluten free.
Package Label Principal Display Panel:
Product label image description image description