NDC 63956-003 Emmi-dent Whitening

Sodium Fluoride

NDC Product Code 63956-003

NDC Product Information

Emmi-dent Whitening with NDC 63956-003 is a a human over the counter drug product labeled by Emag Ag. The generic name of Emmi-dent Whitening is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Emag Ag

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.

Emmi-dent 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.

  • SODIUM FLUORIDE 320 mg/75mL

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)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • ZINC CHLORIDE (UNII: 86Q357L16B)

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: Emag Ag
Labeler Code: 63956
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: 07-30-2019 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.

Emmi-dent Whitening Product Label Images

Emmi-dent 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

Distributed by Ultra Oral Care Inc., Spring, Texas, 77386

Active Ingredient

Sodium Fluoride 0.32% (0.19% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

Helps protect against cavities

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 yrs. of age.If more than used for dental cleaning is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • *adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist*do not swallow*to minimize swallowing use a pea-sized amount in children unter 6*supervise children's dental cleaning until good habits are established*children under 2 yrs.: ask a dentist

Inactive Ingredients

Sorbitol, water, hydrated silica, sodium bicarbonate, propylene glycol, pentasodium triphosphate, C-14-16 olefin sulfonate, celluose gum, aroma/fragrance, titanium dioxide, sodium saccharin, zinc chloride

Questions?

1-833-682-8902

* Please review the disclaimer below.

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