NDC 42681-5276 365 Everyday Value Kids Flouride

Sodium Monofluorophosphate

NDC Product Code 42681-5276

NDC 42681-5276-9

Package Description: 119 g in 1 TUBE

NDC Product Information

365 Everyday Value Kids Flouride with NDC 42681-5276 is a a human over the counter drug product labeled by Whole Foods Market, Inc.. The generic name of 365 Everyday Value Kids Flouride is sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Whole Foods Market, Inc.

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.


365 Everyday Value Kids Flouride 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 MONOFLUOROPHOSPHATE .76 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

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: Whole Foods Market, Inc.
Labeler Code: 42681
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: 03-06-2019 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.

365 Everyday Value Kids Flouride Product Label Images

365 Everyday Value Kids 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

Other

Drug Facts

DISTRIBUTED BY:WHOLE FOODS MARKETAUSTIN, TX 78703www.wholefoods.comPRODUCT OF USA

Otc - Active Ingredient

Active ingredientSodium monofluorophosphate 0.76%

Otc - Purpose

PurposeAnticavity

Indications & Usage

Useaids in the prevention of dental cavities

Warnings

Warning

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

  • DirectionsAdults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age 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

Inactive Ingredient

Inactive ingredients glycerin, water, calcium carbonate, hydrated silica, carrageenan, sodium sauroyl sarcosinate, natural flavors.

Storage And Handling

Other informationStore in a cool dry place. Keep tube capped when not in use.Tamper evident, use only if seal is intact.

Otc - Questions

  • Questions or comments?customer.questions@wholefoods.com1 (844) 936-8255

* Please review the disclaimer below.

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