NDC 75065-006 Spotlight Oral Care For Gum Health

Sodium Fluoride

NDC Product Code 75065-006

NDC 75065-006-02

Package Description: 1 TUBE in 1 CARTON > 100 g in 1 TUBE

NDC Product Information

Spotlight Oral Care For Gum Health with NDC 75065-006 is a a human over the counter drug product labeled by Oral Spotlight Care Inc. The generic name of Spotlight Oral Care For Gum Health is sodium fluoride. The product's dosage form is paste and is administered via dental form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 416783.

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Spotlight Oral Care For Gum Health 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)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ZINC LACTATE (UNII: 2GXR25858Y)

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: Oral Spotlight Care Inc
Labeler Code: 75065
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: 06-11-2021 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".

* Please review the disclaimer below.

Spotlight Oral Care For Gum Health Product Label Images

Spotlight Oral Care For Gum Health 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 ingredient  Sodium Fluoride 0.24%

Otc - Purpose

Purpose  Anticavity

Indications & Usage

Use  aids in the prevention of dental decay.

Warnings

Warnings

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. Ifmore 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 thoroughly, 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 brushingand rinsing habits (to minimize swallowing), and only use apea size amount • Supervise children as necessary untilcapable of using without supervision.• Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredient

Inactive IngredientsSorbitol, Water (purified), Hydrated Silica, Glycerin,Sodium Bicarbonate, Pentasodium Triphosphate,Cocamidopropyl Betaine, Cellulose Gum, Titanium Dioxide,Zinc Lactete, Flavor

Otc - Questions

Questions?  +1 (646) 9806461

Product Labeling

Spotlight Oral CareCREATED BY DENTISTSGToothpastefor GumHealth_______ Active Ingredient _________              Sodium Fluoride___________________________NET WT 3.5oz (100g)MADE IN THE USASpotlight Oral Care, 90 South Dale, Suite #8Saint Paul, Minnesota, USA 55102SpotlightOralCare.com#LoveYourSmileCartonTuberes

* Please review the disclaimer below.