NDC 37000-925 Burts Bees Extra White Zen Peppermint

Sodium Fluoride

NDC Product Code 37000-925

NDC Code: 37000-925

Proprietary Name: Burts Bees Extra White Zen Peppermint Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 37000 - Procter & Gamble Manufacturing Company
    • 37000-925 - Burts Bees

NDC 37000-925-47

Package Description: 1 TUBE in 1 CARTON > 133 g in 1 TUBE

NDC Product Information

Burts Bees Extra White Zen Peppermint with NDC 37000-925 is a a human over the counter drug product labeled by Procter & Gamble Manufacturing Company. The generic name of Burts Bees Extra White Zen Peppermint is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: 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 Additional informationCallout TooltipWhat 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.


Burts Bees Extra White Zen Peppermint Active Ingredient(s)

Additional informationCallout TooltipWhat 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 1.3 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
  • SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Procter & Gamble Manufacturing Company
Labeler Code: 37000
FDA Application Number: part355 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-09-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Burts Bees Extra White Zen Peppermint Product Label Images

Burts Bees Extra White Zen Peppermint 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

*contains one of these ingredients




**Peppermint Oil and other Natural Flavor

DISTR. BY SUNFLOWER DISTRIBUTING




LLC, CINCINNATI, OH 45202

Active Ingredient

Sodium fluoride 0.243% (0.13% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

Helps protect against cavities

Otc - Keep Out Of Reach Of Children

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

Glycerin, water, hydrated silica, sodium cocoyl glutamate*, cocamidopropyl betaine*, flavor**, xanthan gum, carrageenan, stevia rebaudiana extract, titanium dioxide

Questions?

1-855-248-5352

* Please review the disclaimer below.

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