NDC 55910-324 Dg Health Restore And Defend Sensitive

Stannous Fluoride

NDC Product Code 55910-324

NDC Code: 55910-324

Proprietary Name: Dg Health Restore And Defend Sensitive 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: Stannous 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
  • 55910 - Dolgencorp, Llc
    • 55910-324 - Dg Health

NDC 55910-324-19

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

NDC Product Information

Dg Health Restore And Defend Sensitive with NDC 55910-324 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Dg Health Restore And Defend Sensitive is stannous fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Dolgencorp, Llc

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.


Dg Health Restore And Defend Sensitive 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.

  • STANNOUS FLUORIDE .454 g/100g

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.

  • 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)

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: Dolgencorp, Llc
Labeler Code: 55910
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-11-2019 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.

Dg Health Restore And Defend Sensitive Product Label Images

Dg Health 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

DISTRIBUTED BY DOLGENCORP, LLC100 MISSION RIDGEGOODLETTSVILLE, TN 37072

Otc - Active Ingredient

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

Otc - Purpose

PurposeAnticavity/Antihypersensitivity

Indications & Usage

  • Usesaids in the prevention of dental cavitiesbuilds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

Warnings

Warnings

Otc - When Using

When using this product, if irritation occurs discontinue use.

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.Do not swallowChildren under 12 years of age: consult a dentist or doctor

Storage And Handling

  • Other informationproducts containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.This product is specifically formulated to help prevent staining.store below 30°C (86°F)

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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