Ionite H
Sodium Fluoride, Potassium Nitrate
Dharma Research, Inc.
Human Prescription Drug
NDC 53045-280Ionite H also known as Sodium Fluoride, Potassium Nitrate is a human prescription drug labeled by 'Dharma Research, Inc.'. National Drug Code (NDC) number for Ionite H is 53045-280. This drug is available in dosage form of Gel, Dentifrice. The names of the active, medicinal ingredients in Ionite H drug includes Potassium Nitrate - 5 mg/100g Sodium Fluoride - 1.1 mg/100g . The currest status of Ionite H drug is Active.
Drug Information:
| Drug NDC: | 53045-280 |
| 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 H |
| 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, Potassium Nitrate |
| 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: | Gel, Dentifrice |
| 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: | POTASSIUM NITRATE - 5 mg/100g
SODIUM FLUORIDE - 1.1 mg/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: | 02 Aug, 2015 |
| 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: | 637365
|
| 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: | RU45X2JN0Z
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 |
|---|
| 53045-280-04 | 122 g in 1 TUBE (53045-280-04) | 02 Aug, 2015 | 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 h sodium fluoride, potassium nitrate sodium fluoride fluoride ion potassium nitrate nitrate ion .alpha.-tocopherol carbomer homopolymer type c (allyl pentaerythritol crosslinked) edetic acid glycerin sodium hydroxide sodium polymetaphosphate tricalcium phosphate water xylitol
Indications and Usage:
Indications and usage this is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.
Warnings and Cautions:
Warnings and precautions do not swallow. keep out of reach of children. read prescribing information fully before using this product. if product is accidentially swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. sensitive teeth may indicate a serious problem that may need prompt care by a dentist. see your dentist if the problem persists or worsens. do not use this product for longer than 4 weeks unless recommended by a dentist or physician.
Dosage and Administration:
Dosage and administration use twice per day (morning and evening) in place of regular toothpaste or as recommended by a dentist or physician. adults and children 12 years of age and older: twist off cap and remove foil seal. apply at least a 1 inch strip gel onto a soft bristle tooth brush. brush teeth thoroughly for at least 1 minute, spit out, and rinse mouth thoroughly. make sure to brush all sensitive areas of the teeth. children under 12 years of age: consult a dentist or physician.
Dosage Forms and Strength:
Dosage forms and strengths gel containing 1.1% sodium fluoride and 5% potassium nitrate.
Contraindications:
Contraindications avoid use in patients with known hypersensitivity to fluoride. do not use in pediatric patients under 12 unless directed by a dentist or physician.
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 h neutral fluoride gel is a flavored, ph neutral 1.1% sodium fluoride, 5% potassium nitrate gel that aids in the prevention of dental decay and hleps to treat sensitive teeth.
How Supplied:
How supplied/storage 4.3 ounces (122 g) in a plastic tube. store at room temperature 59 â 86°f (15 â 30°c).
Package Label Principal Display Panel:
Ionite h ndc 53045-280-04 home care 1.1% neutral fluoride gel with xylitol and vitamin e spearmint rx only made in usa gluten free dye free re-order#: 56-00140 4.3 oz. (122 g) 20150802 280 nafkno3 spmnt reva