NDC 73597-019 Royal Whitening Pre-brush

Alcohol, Hydrogen Peroxide, Menthol

NDC Product Code 73597-019

NDC CODE: 73597-019

Proprietary Name: Royal Whitening Pre-brush What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Alcohol, Hydrogen Peroxide, Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 73597 - Mission Series Inc. Dba Prestige Beauty Care

NDC 73597-019-16

Package Description: 499.7 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Royal Whitening Pre-brush with NDC 73597-019 is a a human over the counter drug product labeled by Mission Series Inc. Dba Prestige Beauty Care. The generic name of Royal Whitening Pre-brush is alcohol, hydrogen peroxide, menthol. The product's dosage form is rinse and is administered via oral form.

Labeler Name: Mission Series Inc. Dba Prestige Beauty Care

Dosage Form: Rinse - A liquid used to cleanse by flushing.

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.

Royal Whitening Pre-brush 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.

  • HYDROGEN PEROXIDE .5 mg/mL
  • MENTHOL .15 mg/mL
  • ALCOHOL .8 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Mission Series Inc. Dba Prestige Beauty Care
Labeler Code: 73597
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 01-25-2021 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 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.

Royal Whitening Pre-brush Product Label Images

Royal Whitening Pre-brush 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 Ingredients

Active IngredientsAlcohol 8%Hydrogen Peroxide 0.5%Menthol 0.15%

Purpose

PurposeAntigingivitus/Antiplaque

Uses

Uses aids in the prevention of dental cavities.

Warnings

Do not use in children under 12 years of age.

Keep Out Of Reach Of Children

Keep out of reach of children.

Other Information

Other Information • Store at room temperature

Directions

Directions Before brushing, rinse full strength for 60 seconds with 1/2 fluid ounce (15 mL or 3 teaspoons) morning and night. Do not swallow. Do not use more than 2 times a day.

Inactive Ingredients

Inactive Ingredients Water, Sodium Phosphate, Poloxamer, Sodium Lauryl Sulfate, Sodium Citrate, Sodium Saccharin, Sucralose.

Distributed By:

Distributed By:PRESTIGE BEAUTY CARE1585 West Mission Blvd.Pomona, CA 91766Made in ChinaThis product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Listerine®

* Please review the disclaimer below.