NDC 41250-530 Meijer Restore And Defend Sensitive

Stannous Fluoride

NDC Product Code 41250-530

NDC 41250-530-19

Package Description: 1 TUBE in 1 CARTON > 96.4 g in 1 TUBE

NDC Product Information

Meijer Restore And Defend Sensitive with NDC 41250-530 is a a human over the counter drug product labeled by Meijer Distribution Inc. The generic name of Meijer Restore And Defend Sensitive is stannous fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Meijer Distribution 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.


Meijer Restore And Defend Sensitive 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.

  • STANNOUS FLUORIDE .454 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)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)

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: Meijer Distribution Inc
Labeler Code: 41250
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-25-2019 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.

Meijer Restore And Defend Sensitive Product Label Images

Meijer Restore And Defend Sensitive 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

DIST. BYMEIJER DISTRIBUTION, INC.GRAND RAPIDS, MI 49544www.meijer.comMADE IN USA

Otc - Active Ingredient

Active ingredientStannous Fluoride 0.454% (w/v 0.15% fluoride ion)

Otc - Purpose

PurposeAnticavity/Antihypersensitivity

Indications & Usage

  • Usesbuilds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contactaids in the prevention of dental cavities

Warnings

WarningsIf pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Otc - Stop Use

  • Stop use and ask a dentist if: the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.pain/sensitivity still persists after 4 weeks of use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. 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 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.Minimize swallowingSpit out after brushingChildren under 12 years of age: consult a dentist or doctor

Inactive Ingredient

Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

* Please review the disclaimer below.

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