NDC 81740-001 Auraglow Whitening

Sodium Fluoride

NDC Product Code 81740-001

NDC 81740-001-01

Package Description: 1 TUBE in 1 CARTON > 113 g in 1 TUBE

NDC Product Information

Auraglow Whitening with NDC 81740-001 is a a human over the counter drug product labeled by Auraglow Llc. The generic name of Auraglow Whitening is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 891775.

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.

Auraglow Whitening 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.


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.

  • SORBITOL (UNII: 506T60A25R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
  • SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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: Auraglow Llc
Labeler Code: 81740
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: 07-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Auraglow Whitening Product Label Images

Auraglow Whitening 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

Otc - Active Ingredient

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

Otc - Purpose

Purpose  Anticavity

Indications & Usage

Use  Aids in 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, getmedical help or contact a Poison Control Center right away.

Dosage & Administration

Directions • Adults and children 2 years of age andolder: Brush teeth thouroughly, preferably after each meal orat 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 IngredientsSorbitol, hydrated silica, deionized water,glycerin, hydrogen peroxide, polyethyleneglycol, sodium tripolyphosphate, cellulosegum, sodium methyl cocoyl tautate,flavor, stevia, sodium bicarbonate

Package Labeling

​AuraglowWhitening ToothpasteWintergreenC​ONTAINS FLUORIDE &3% HYDROGEN PEROXIDENET WT 4.0 OZ (113G)Distr. by Auraglow LLC, Stamford, CT 06901res

* Please review the disclaimer below.