NDC 69491-200 Delta One 2019 Tumi Collins And Tumi Collins Bombas Amenity With Crest 3d White Brilliance

Sodium Fluoride

NDC Product Code 69491-200

NDC Code: 69491-200

Proprietary Name: Delta One 2019 Tumi Collins And Tumi Collins Bombas Amenity With Crest 3d White Brilliance 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

  • 69491 - Buzz Export Services Pty., Ltd.
    • 69491-200 - Delta One 2019 Tumi Collins And Tumi Collins Bombas Amenity With Crest 3d White Brilliance

NDC 69491-200-00

Package Description: 1 KIT in 1 KIT * 24 g in 1 TUBE (37000-873-01)

NDC Product Information

Delta One 2019 Tumi Collins And Tumi Collins Bombas Amenity With Crest 3d White Brilliance with NDC 69491-200 is a a human over the counter drug product labeled by Buzz Export Services Pty., Ltd.. The generic name of Delta One 2019 Tumi Collins And Tumi Collins Bombas Amenity With Crest 3d White Brilliance is sodium fluoride. The product's dosage form is kit and is administered via form.

Labeler Name: Buzz Export Services Pty., Ltd.

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • POLYETHYLENE OXIDE 900000 (UNII: 16P9295IIL)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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

Labeler Name: Buzz Export Services Pty., Ltd.
Labeler Code: 69491
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: 04-01-2019 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.

Delta One 2019 Tumi Collins And Tumi Collins Bombas Amenity With Crest 3d White Brilliance Product Label Images

Delta One 2019 Tumi Collins And Tumi Collins Bombas Amenity With Crest 3d White Brilliance 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

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

Helps protect against cavities

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, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, PEG-20M or PEG-23M, xanthan gum, sucralose, mica, titanium dioxide

Questions?

1-800-492-7378

* Please review the disclaimer below.

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