Pro-den Rx
Sodium Fluoride
Den-mat Holdings, Llc
Human Prescription Drug
NDC 59883-911Pro-den Rx also known as Sodium Fluoride is a human prescription drug labeled by 'Den-mat Holdings, Llc'. National Drug Code (NDC) number for Pro-den Rx is 59883-911. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Pro-den Rx drug includes Sodium Fluoride - 9 mg/mL . The currest status of Pro-den Rx drug is Active.
Drug Information:
| Drug NDC: | 59883-911 |
| 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 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: | 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: | SODIUM FLUORIDE - 9 mg/mL
|
| 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: | 21 Oct, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Jun, 2026 |
| 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: | 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: | 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 |
|---|
| 59883-911-64 | 1890 mL in 1 BOTTLE, PLASTIC (59883-911-64) | 21 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. |
Product Elements:
Pro-den rx sodium fluoride water polyoxyl 40 hydrogenated castor oil sodium benzoate sodium phosphate, dibasic, anhydrous saccharin sodium methylparaben sodium phosphate d&c yellow no. 10 fd&c blue no. 1 sodium fluoride fluoride ion mint
Indications and Usage:
Indications and usage for topical application to aid in the protection against dental caries. neutral ph is especially safe for crowns and restorations.
Warnings and Cautions:
Warnings and precautions for professional office use only. this product is not intended for home or unsupervised consumer use. do not swallow. keep out of reach of children. not recommended for children under the age of 6. limited to topical use in the mouth only.
Dosage and Administration:
Dosage and administration dispense ½ oz. (approx. 1 pump) of pro-denrx 2.0% neutral sodium fluoride solution into the provided mixing cup. instruct patient to rinse vigorously for 30 seconds with ½ oz. of the solution around and between teeth, then expectorate. for maximum benefit repeat the rinse procedure with an additional ½ oz. of solution. pro-denrx 2.0% neutral sodium fluoride solution may also be applied full strength, with cotton pledgets, to teeth isolated with cotton rolls.
Contraindications:
Contraindications hypersensitivity to fluoride.
Adverse Reactions:
Adverse reactions the following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.
Overdosage:
Overdosage accidental ingestion of large amounts of fluoride can cause: nausea, vomiting, abdominal pain, diarrhea, stupor and/ or weakness (usually within 30 minutes). these symptoms may persist for 24 hours. if less than 5 mg fluoride/kg body weight (less than 23 mg fluoride/lb body weight) has been ingested, give calcium (milk) orally to relieve symptoms and observe for a few hours. if more than 5 mg fluoride/kg body weight (more than 23 mg fluoride/lb body weight) has been ingested, induce vomiting, give calcium (i.e., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. for accidental ingestion of more than 15 mg fluoride/kg body weight (i.e., more than 6.9 mg fluoride/lb body weight) induce vomiting, transport and admit immediately to a hospital facility.
How Supplied:
How supplied/storage and handling 2.0% neutral sodium fluoride (0.9% fluoride ion) oral solution supplied in a plastic bottle with child-resistant closure containing 64 fl. oz. (1.89 l). store at room temperature. protect from freezing. do not store in direct sunlight. rx only revised: 12/2017 1-800-433-6628 reorder number: 2037mtdt manufactured for den-mat holdings, llc 1017 w. central ave. lompoc, ca 9343611 ©2017 den-mat holdings, llc. all rights reserved. 001395000 12/17as
Package Label Principal Display Panel:
Principal display panel - 64 fl. oz. bottle label ndc 59883-911-64 treatment rinse 2.0% neutral sodium fluoride cool mint flavor important: read directions for proper use. net wt. 64 fl. oz. (1.89 l) rinse_fluoride_image