NDC 69842-254 Pro Defense Mint

Stannous Fluoride

NDC Product Code 69842-254

NDC Product Information

Pro Defense Mint with NDC 69842-254 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Pro Defense Mint is stannous fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Cvs Pharmacy

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.


Pro Defense Mint 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.

  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • WATER (UNII: 059QF0KO0R)

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: Cvs Pharmacy
Labeler Code: 69842
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: 02-08-2019 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.

Pro Defense Mint Product Label Images

Pro Defense Mint 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 stannous fluoride, clinically proven to help control bleeding gums.Distributed by:CVS Pharmacy, Inc.One CVS DriveWoonsocket, RI 02895©2018 CVS/pharmacyCVS.com1-800-SHOP CVS

Otc - Active Ingredient

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

Otc - Purpose

PurposeAnticavity / Antigingivitis

Indications & Usage

  • Usesaids in the prevention of dental cavitieshelps control bleeding gumshelps interfere with harmful effects of plaque associated with gingivitis

Warnings

Warnings

Otc - When Using

When using this product, if irritation occurs discontinue use.

Otc - Stop Use

  • Stop use and ask a dentist if:gingivitis, bleeding or redness persists for more than 2 weeksif you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be symptoms of periodontis, a serious form of gum disease

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 thoroughly, preferably after each meal or at least twice a day and not more than 3 times a day or as day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing
Children under 2 years of age: consult a dentist or doctor

Storage And Handling

  • Other information products containing stannous fluoride may cause surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed your dentist.This product is specifically formulated to help prevent stainingstore below 77°F (25°C)Keep tube capped when not in use

Inactive Ingredient

Inactive ingredients Glycerin, Water, Hydrated Silica, Pentasodium Triphosphate, Cellulose Gum, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin

* Please review the disclaimer below.

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