Ionite H
Stannous Fluoride
Dharma Research, Inc.
Human Otc Drug
NDC 53045-271Ionite H also known as Stannous Fluoride is a human otc drug labeled by 'Dharma Research, Inc.'. National Drug Code (NDC) number for Ionite H is 53045-271. This drug is available in dosage form of Gel, Dentifrice. The names of the active, medicinal ingredients in Ionite H drug includes Stannous Fluoride - .4 mg/100g . The currest status of Ionite H drug is Active.
Drug Information:
| Drug NDC: | 53045-271 |
| 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 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: | 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: | STANNOUS FLUORIDE - .4 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: | 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: | 02 Aug, 2015 |
| 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: | Dharma Research, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 237847
|
| 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 |
|---|
| 53045-271-04 | 122 g in 1 TUBE (53045-271-04) | 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. |
Purpose:
Purpose anticavity
Product Elements:
Ionite h stannous fluoride stannous fluoride fluoride ion carbomer homopolymer type c (allyl pentaerythritol crosslinked) citric acid monohydrate glycerin sodium hydroxide water xylitol
Indications and Usage:
Uses aids in the prevention of dental cavities (caries).
Warnings:
Warnings keep out of reach of children. if more that used for brushing is accidentally swallowed, get medical help or contact a poison control center right away. do not swallow. supervision of children is required when using this product. developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.
Supervision of children is required when using this product. developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.
Do Not Use:
Warnings keep out of reach of children. if more that used for brushing is accidentally swallowed, get medical help or contact a poison control center right away. do not swallow. supervision of children is required when using this product. developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.
Supervision of children is required when using this product. developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.
Dosage and Administration:
Directions ⢠this is not a toothpaste. read directions carefully before using. ⢠adults and children 6 years of age and older: o use once per day after brushing teeth thoroughly with toothpaste o twist off cap to remove foil seal o apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces. o allow the gel to remain on your teeth for 1 minute o spit out. do not swallow o do not eat, drink, or rinse for at least 30 minutes ⢠children under 6: consult a dentist or doctors
Package Label Principal Display Panel:
Ionite h ndc 53045-271-04 home care 0.4% stannous fluoride gel with xylitol anticavity fluoride preventative treatment gel bubble gum made in usa gluten free dye free reorder#: 56-00131 4.3 oz. (122 g) 20150802 271 snf2 bubgm revb