NDC 73656-017 White Glo Mouthwash Protection

Sodium Monofluorophosphate

NDC Product Code 73656-017

NDC 73656-017-00

Package Description: 1 KIT in 1 KIT * 1 TUBE in 1 CARTON (73656-018-00) > 150 g in 1 TUBE

NDC Product Information

White Glo Mouthwash Protection with NDC 73656-017 is a a human over the counter drug product labeled by White Glo Usa Inc. The generic name of White Glo Mouthwash Protection is sodium monofluorophosphate. The product's dosage form is kit and is administered via form.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM SILICATE (UNII: IJF18F77L3)
  • THYMOL (UNII: 3J50XA376E)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: White Glo Usa Inc
Labeler Code: 73656
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: 11-01-2021 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".

* Please review the disclaimer below.

White Glo Mouthwash Protection Product Label Images

White Glo Mouthwash Protection 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

Active Ingredient

Sodium monofluorophosphate 0.76%(0.1% W/V fluoride ion)

Purpose

Anticavity toothpaste

Use

Helps pretect against cavities

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 rightaway.

Directions

Adults and children 2 years of age & older:  Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age:  Instruct 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.

Other Information

  • Store in a cool place, below 86°F, away from heatDo not use if quality seal is broken or missing

Inactive Ingredients

Calcium Carbonate, Water, Sorbitol, Glycerin, Silica, Alcohol, Sodium Lauryl Sulfate, Flavor, Carrageenan, Cellulose Gum, Hydroxyethylcellulose, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Thymol, Rosa Canina Fruit Oil

* Please review the disclaimer below.