NDC 61649-732 Bio Spectra Attitude

Sodium Fluoride

NDC Product Code 61649-732

NDC 61649-732-01

Package Description: 120 g in 1 TUBE

NDC Product Information

Bio Spectra Attitude with NDC 61649-732 is a a human over the counter drug product labeled by Bio Spectra. The generic name of Bio Spectra Attitude is sodium fluoride. The product's dosage form is gel, dentifrice and is administered via dental form.

Labeler Name: Bio Spectra

Dosage Form: Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Bio Spectra Attitude Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM FLUORIDE .243 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CARICA PAPAYA LEAF (UNII: 66J7636Z2I)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bio Spectra
Labeler Code: 61649
FDA Application Number: part355 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-15-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Bio Spectra Attitude Product Label Images

Bio Spectra Attitude Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

DRUG FACTS

Active Ingredient

Sodium fluoride (0.243% w/w)

Purpose

Anti-cavity

Uses

  • Prevents, fights and protects against cavities.Effective fluoride protection.Protects teeth from acid erosion.Penetrates tooth enamel to help rebuild weak spots.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, call a poison control centre or get medical help right away.

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. Children under 6 years of age should use only a pea-sized amount and be supervised to brush properly and to not swallow. Consult a dentist or health care professional before using with children under 2 years of age. Store at room temperature (15-30 °C).

Non-Medicinal Ingredients

Sorbitol, aqua, glycerin, hydrated silica, sodium lauryl sulfate, gaultheria procumbens (wintergreen) leaf oilNaturally contains: D-limonene., xanthan gum, citric acid, stevia rebaudiana leaf / stem extract, sodium benzoate, carica papaya leaf extract, camellia sinensis (green tea) leaf extract, sodium bicarbonate, titanium dioxide, potassium sorbate, hydroxyapatite.

Questions?

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* Please review the disclaimer below.