NDC 73656-007 White Glo Professional Choice

Sodium Monofluorophosphate

NDC Product Code 73656-007

NDC 73656-007-00

Package Description: 1 KIT in 1 KIT * 150 g in 1 TUBE (73656-008-00)

NDC Product Information

White Glo Professional Choice with NDC 73656-007 is a a human over the counter drug product labeled by White Glo Usa Inc. The generic name of White Glo Professional Choice is sodium monofluorophosphate. The product's dosage form is kit and is administered via form.

Labeler Name: White Glo Usa Inc

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)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM SILICATE (UNII: IJF18F77L3)
  • SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • 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: 02-15-2020 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: 12-31-2021 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.

White Glo Professional Choice Product Label Images

White Glo Professional Choice 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 protect 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 right away.

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 heat Do not use if quality seal is broken or missing

Inactive Ingredients

Calcium carbonate, water, sorbitol, glycerin, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium phosphate, cellulose gum, hydroxyethylcellulose, rosa canina (rose hip) fruit oil

* Please review the disclaimer below.