NDC 72299-021 Humble Brush Bamboo With Fresh Mint Flouride

Sodium Fluoride

NDC Product Code 72299-021

NDC CODE: 72299-021

Proprietary Name: Humble Brush Bamboo With Fresh Mint Flouride 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.

NDC Code Structure

  • 72299 - The Humble Company North America Inc
    • 72299-021 - Humble Brush Bamboo With Fresh Mint Flouride

NDC 72299-021-01

Package Description: 1 KIT in 1 KIT * 7 g in 1 TUBE (72299-022-01)

NDC Product Information

Humble Brush Bamboo With Fresh Mint Flouride with NDC 72299-021 is a a human over the counter drug product labeled by The Humble Company North America Inc. The generic name of Humble Brush Bamboo With Fresh Mint Flouride is sodium fluoride. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 891775.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)

Product Labeler Information

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

Labeler Name: The Humble Company North America Inc
Labeler Code: 72299
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: 09-01-2021 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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Humble Brush Bamboo With Fresh Mint Flouride Product Label Images

Humble Brush Bamboo With Fresh Mint Flouride 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

Active Ingredient

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

Purpose

Anticavity Toothpaste

Use

Aids in the prevention of dental cavities

Keep Out Of Reach Of Children Under 6 Years 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 years of age and older  Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age  Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age  Consult a dentist or doctor.

Other Information

Store below 25°C (77°F)

Inactive Ingredients

Calcium carbonate, deionized water, sorbitol, glycerin, sodium lauryl sulfate, sodium carboxymethyl cellulose, mint flavour, hythyl cellulose, sodium fluoride, sodium saccharin, titanium dioxide, benzoate sodium

Questions?

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