Bio Spectra Attitude
Sodium Fluoride And Potassium Nitrate
Attitude Dba 9055-7588 Qubec Inc.
Human Otc Drug
NDC 61649-733Bio Spectra Attitude also known as Sodium Fluoride And Potassium Nitrate is a human otc drug labeled by 'Attitude Dba 9055-7588 Qubec Inc.'. National Drug Code (NDC) number for Bio Spectra Attitude is 61649-733. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Bio Spectra Attitude drug includes Potassium Nitrate - 5 g/100g Sodium Fluoride - .243 g/100g . The currest status of Bio Spectra Attitude drug is Active.
Drug Information:
| Drug NDC: | 61649-733 |
| 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: | Bio Spectra Attitude |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Bio Spectra |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | ATTITUDE |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Sodium Fluoride And Potassium Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Attitude Dba 9055-7588 Qubec Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Paste, 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 g/100g
SODIUM FLUORIDE - .243 g/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 NOT 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: | 15 May, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | part356 |
| 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: | Attitude DBA 9055-7588 Qubec Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1038800
|
| 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 |
|---|
| 61649-733-01 | 120 g in 1 TUBE (61649-733-01) | 15 May, 2021 | 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:
Active ingredients purpose sodium fluoride (0.243% w/w) anti-cavity potassium nitrate (5% w/w) anti-hypersensitivity
Product Elements:
Bio spectra attitude sodium fluoride and potassium nitrate sodium fluoride fluoride ion potassium nitrate nitrate ion sorbitol water hydrated silica glycerin sodium lauryl sulfate methyl salicylate xanthan gum anhydrous citric acid stevia rebaudiuna leaf sodium benzoate carica papaya leaf green tea leaf potassium sorbate opaque
Indications and Usage:
Uses builds protection against sensitivity of the teeth. shields and soothes dental nerves for lasting sensitivity relief when used regularly. prevents, fights and protects against cavities. effective fluoride protection. protects teeth from acid erosion. penetrates tooth enamel to help rebuild weak spots.
Warnings:
Warnings keep out of reach of children. if swallowed, call a poison control centre or get medical help right away. sensitive teeth may indicate a serious problem. stop use and consult a health care professional if symptoms persist or worsen.
Dosage and Administration:
Directions do not swallow. should be used as part of an oral health program that includes regular flossing and dental check-ups. brush teeth thoroughly for at least 1 minute twice a day, preferably after each meal, or as directed by a dentist or health care professional. not recommended for children under 12 years of age. store at room temperature (15-30 °c).
Stop Use:
Sensitive teeth may indicate a serious problem. stop use and consult a health care professional if symptoms persist or worsen.
Package Label Principal Display Panel:
Principal display panel - 120 g tube label attitude ® bio spectra natural care anticavity ⢠with fluoride toothpaste sensitive spearmint ⢠ewg verified ⢠for your health ⢠ewg.org npn 80104614 gel ⢠120 g ⮠4.2 oz. principal display panel - 120 g tube label
Further Questions:
Questions? +1 (514) 509-7225