Pro-den Rx
Stannous Fluoride
Den-mat Holdings, Llc
Human Otc Drug
NDC 59883-720Pro-den Rx also known as Stannous Fluoride is a human otc drug labeled by 'Den-mat Holdings, Llc'. National Drug Code (NDC) number for Pro-den Rx is 59883-720. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Pro-den Rx drug includes Stannous Fluoride - 1.53 mg/g . The currest status of Pro-den Rx drug is Active.
Drug Information:
| Drug NDC: | 59883-720 |
| 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: | Pro-den Rx |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Den-mat Holdings, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| 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 - 1.53 mg/g
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 31 Oct, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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. |
| Application Number: | part355 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Den-mat Holdings, Llc
|
| 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: | 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 |
|---|
| 59883-720-08 | 1 BOTTLE in 1 CARTON (59883-720-08) / 283.5 g in 1 BOTTLE | 31 Oct, 2008 | 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. |
Purpose:
Purpose anticavity
Product Elements:
Pro-den rx stannous fluoride glycerin methylparaben propylparaben saccharin sodium stannous fluoride fluoride ion mint
Indications and Usage:
Uses aids in the prevention of dental caries (cavities). control of perio infection relief of dentin sensitivity
Warnings:
Warnings when using this product it may produce surface staining of the teeth. adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. keep out of reach of children. if more than used for rinsing s accidentally swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product it may produce surface staining of the teeth. adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Dosage and Administration:
Directions do not use before mixing with water use immediately after preparing the rinse adults and children 6 years of age and older: use as directed by a dental professional use once a day after brushing your teeth with a toothpaste or as directed by your dentist remove cap and seal and replace with pump rotate spout counter clockwise to extend depress pump until medicine comes to the tip of the pump put 1/8 oz. (approx. 2 pump strokes) of concentrated pro-denrx rinse into the provided mixing vial add water to 1 oz. line on mixing vial tightly snap on the cap and shake well vigorously swish between your teeth 1/2 of mixture for one minute and then spit out repeat procedure with remaining mixture rinse mixing vial with water after use do not swallow the rinse do not eat or drink for 30 minutes after rinsing children 6 to 12 years of age: instruct children in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children
Read more... under 6 years of age: consult a dentist or doctor for home irrigation prepare 1 oz. of pro-denrx rinse as described above pour into irrigator reservoir, add 4 oz. of water and mix thoroughly use irrigator as directed rinse irrigator with water after use
Package Label Principal Display Panel:
Principal display panel - carton label ndc 59883-720-08 pro-denrx ® dye free rinse 0.63 % stannous fluoride cool mint flavor important: read directions for proper use. 10 fl. oz. (283.5 g) figure
Principal display panel - tube label ndc 59883-720-08 pro-denrx ® dye free rinse 0.63 % stannous fluoride mint flavor important: read directions for proper use. 10 fl. oz. (283.5 g) figure