Gingimed
Stannous Fluoride
Massco Dental
Human Prescription Drug
NDC 63783-212Gingimed also known as Stannous Fluoride is a human prescription drug labeled by 'Massco Dental'. National Drug Code (NDC) number for Gingimed is 63783-212. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Gingimed drug includes Stannous Fluoride - .19 g/100g . The currest status of Gingimed drug is Active.
Drug Information:
| Drug NDC: | 63783-212 |
| 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: | Gingimed |
| 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: | Stannous Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Massco Dental |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | STANNOUS FLUORIDE - .19 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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 Jan, 1989 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | Massco Dental
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 583459
750102
|
| 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: | 3FTR44B32Q
|
| 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 |
|---|
| 63783-212-06 | 120 g in 1 BOTTLE, WITH APPLICATOR (63783-212-06) | 01 Jan, 1989 | 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:
Gingimed stannous fluoride stannous fluoride fluoride ion glycerin xylitol mint gingimed stannous fluoride stannous fluoride fluoride ion glycerin xylitol caribbean ice gingimed stannous fluoride stannous fluoride fluoride ion glycerin xylitol cinnamon
Indications and Usage:
Use approved uses: relief of dentinal hypersensitivity. control of perio infection.
Warnings:
Warnings if more than amount directed for rinsing is accidentally swallowed, seek medical help from a poison control center. do not use before mixing with water. use as directed by a dental professional. this is a fluoride treatment rinse, not a mouthwash.
When Using:
Directions for use adults and children 6 years and older: rinse each day after usual brushing and flossing or more often if your dentist recommends additional therapy based on the diagnosis. push down on pump twice or pour the concentrated rinse to the 1/8 fl. ox. mark on the mixing vial. add water to the 1 oz. line. close tightly with snap-on cap and shake well. this prepares a 0.1% stannous fluoride rinse. rinse with one half of the solution for one minute, expectorate (spit) and repeat the procedure with the remaining half of the mixture. do not swallow and do not rinse mouth. rinse mixing vial with water after each use. children 6-12 years: instruct and supervise in good rinsing habits. (help to minimize swallowing) children under 6: consult a dentist. for home irrigation: prepare 1 oz. of gingimed rinse as described above. pour into irrigator resivoir and add 4 oz. of water. mix thoroughly. use irrigator as described
General Precautions:
Other information this product may cause minimal surface discoloration on the teeth, may be prevented by adequate brushing.
Package Label Principal Display Panel:
Package label alcohol free perio treatment. gingimed 0.63% stannous fluoride read directions thoroughly. mix with water before use. now containing xylitol manufactured by massco dental a division of dunagin pharmaceuticals, gravette, ar (479) 787-5168 www.masscodental.net res cinnamon label mint label carribean ice label