Ionite R
Sodium Fluoride
Dharma Research, Inc.
Human Prescription Drug
NDC 53045-266Ionite R also known as Sodium Fluoride is a human prescription drug labeled by 'Dharma Research, Inc.'. National Drug Code (NDC) number for Ionite R is 53045-266. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Ionite R drug includes Sodium Fluoride - 38 g/L . The currest status of Ionite R drug is Active.
Drug Information:
| Drug NDC: | 53045-266 |
| 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: | Ionite R |
| 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: | Dharma Research, Inc. |
| 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: | SODIUM FLUORIDE - 38 g/L
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
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: | 03 Nov, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Jan, 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: | Dharma Research, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 251960
|
| 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. |
| UPC: | 0353045001021
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 53045-266-64 | 1.9 L in 1 BOTTLE, PUMP (53045-266-64) | 03 Nov, 2013 | 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:
Ionite r sodium fluoride sodium fluoride fluoride ion water sodium benzoate sodium citrate saccharin sodium xylitol
Indications and Usage:
Indications and usage this is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. remove cap from bottle and insert enclosed pump into bottle and tighten. pump ½ oz into a cup. instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. repeat the procedure to ensure maximum benefit. instruct patient not to eat or drink for at least 30 minutes.
Warnings and Cautions:
Warnings and precautions do not swallow. keep out of reach of children. read prescribing information fully before using this product. use in children less than 6 years of age requires special supervision to prevent swallowing. if product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away.
Dosage Forms and Strength:
Dosage form and strength liquid containing 2% sodium fluoride
Contraindications:
Contraindications avoid use in patients with known hypersensitivity to fluoride
Adverse Reactions:
Adverse reactions to report suspected adverse reactions, contact dharma research, inc. at 1-877-833-3725 or the fda at 1-800-fda-1088 or www.fda.gov/medwatch
Description:
Description ionite r fluoride oral rinse is a flavored, ph neutral 2.0% sodium fluoride treatment rinse that aids in the prevention of dental decay. active ingredient: sodium fluoride, 2.0% inactive ingredients: flavor, water, sodium benzoate, sodium citrate, saccharin sodium, xylitol
How Supplied:
How supplied/storage 64 fluid ounces (1.9 l) in a plastic bottle with dispensing pump included. store at room temperature 59-86°f (15-30°c). protect from freezing.
Package Label Principal Display Panel:
Ionite r sodium fluoride rinse 2.0% neutral sodium fluoride dye free fruit punch with xylitol gluten free rx only 64 fl. oz. (1.9 l) manufactured by: dharma research, inc., 5220 nw 72nd avenue, unit 15, miami, fl, 33166 1-877-833-3725 www.dharmaresearch.com ndc 53045-266-64 label revision b, 10/29/13 20131101 266 fuoride rinse fruit punch