NDC 37808-320 Heb Gleaming White Arctic Mint

Sodium Fluoride

NDC Product Code 37808-320

NDC Product Information

Heb Gleaming White Arctic Mint with NDC 37808-320 is a a human over the counter drug product labeled by Heb. The generic name of Heb Gleaming White Arctic Mint is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Heb

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.


Heb Gleaming White Arctic 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.

  • SODIUM FLUORIDE .243 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.

  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SACCHARIN (UNII: FST467XS7D)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
  • MICA (UNII: V8A1AW0880)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Heb
Labeler Code: 37808
FDA Application Number: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-12-2019 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.

Heb Gleaming White Arctic Mint Product Label Images

Heb Gleaming White Arctic 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

Otc - Active Ingredient

Active ingredientSodium fluoride 0.243% (0.15% w/v fluoride ion)

Otc - Purpose

PurposeAnticavity

Indications & Usage

Usesaids in the prevention of dental cavities

Warnings

Warnings

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 per 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.

Storage And Handling

Other information Store in a cool, dry place.
· Keep tube capped when not in use.

Inactive Ingredient

Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

Otc - Questions

Questions or comments?CALL
1-877-777-2743

Other

MADE WITH PRIDE AND CARE FOR H-E-B®SAN ANTONIO, TX 78204

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