NDC 37000-444 Brisa Luminous Whitening

Sodium Fluoride

NDC Product Code 37000-444

NDC CODE: 37000-444

Proprietary Name: Brisa Luminous Whitening What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Fluoride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 37000 - The Procter & Gamble Manufacturing Company

NDC 37000-444-41

Package Description: 1 TUBE in 1 CARTON > 116 g in 1 TUBE

NDC Product Information

Brisa Luminous Whitening with NDC 37000-444 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Brisa Luminous Whitening is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via oral form.

Labeler Name: The Procter & Gamble Manufacturing Company

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.

Brisa Luminous Whitening 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 1.5 mg/g

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.

  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SORBITOL (UNII: 506T60A25R)
  • SACCHARIN (UNII: FST467XS7D)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
  • WATER (UNII: 059QF0KO0R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: The Procter & Gamble Manufacturing Company
Labeler Code: 37000
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: 10-21-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Brisa Luminous Whitening Product Label Images

Brisa Luminous Whitening 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

Drug Facts

Sodium fluoride 0.243%(0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

Helps protect against cavities

Warning

Keep out of reach of children under 6 yrs. of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentistdo not swallowto minimize swallowing use a pea-sized amount in children under 6supervise children's brushing until good habits are establishedchildren under 2 yrs.: ask a dentist

Inactive Ingredients

Water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, sucralose, polysorbate 80, titanium dioxide

Questions?

1-888-654-6409

Other

DISTR. BY/POR AGILE PURSUITSCINCINNATI, OH 45202

116G Tube In Carton

Brisa™TOOTHPASTEflouride toothpasteLuminous WhiteningNET WT 4.1OZ (116g)

* Please review the disclaimer below.