FDA.reportPublic FDA data

Royal Whitening Pre-Brush

Manufacturer
Mission Series Inc. dba Prestige Beauty Care
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:55:10

Label at a glance#

ProductRoyal Whitening Pre-Brush
Active ingredientHYDROGEN PEROXIDE, MENTHOL, ALCOHOL
Label structure10 sections

Indications and uses

Uses aids in the prevention of dental cavities.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Alcohol 8%

Hydrogen Peroxide 0.5%

Menthol 0.15%

Purpose

OTC - PURPOSE SECTION

Purpose

Antigingivitus/Antiplaque

Uses

INDICATIONS & USAGE SECTION

Uses aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Do not use in children under 12 years of age.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Other Information

SPL UNCLASSIFIED SECTION

Other Information • Store at room temperature

Directions

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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

Distributed By:

SPL UNCLASSIFIED SECTION

Distributed By:

PRESTIGE BEAUTY CARE

1585 West Mission Blvd.

Pomona, CA 91766

Made in China

This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Listerine®

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Royal Whitening Pre BrushRoyal Whitening Pre Brush

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73597-01973597-019-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VACTIB
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
SODIUM PHOSPHATESE337SVY37IACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ALCOHOL3K9958V90MACTIB
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f2a5cb86-5603-5cba-e053-2995a90a8c45b9beb5d8-4f5e-6e08-e053-2995a90a080c2023-01-19WarningsExact identifier
spl set id: b9beb5d8-4f5e-6e08-e053-2995a90a080c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.