Royal Whitening Pre-Brush Rinse

Royal Whitening Pre-Brush by

Drug Labeling and Warnings

Royal Whitening Pre-Brush by is a Otc medication manufactured, distributed, or labeled by Mission Series Inc. dba Prestige Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROYAL WHITENING PRE-BRUSH- alcohol, hydrogen peroxide, menthol rinse 
Mission Series Inc. dba Prestige Beauty Care

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Royal Whitening Pre-Brush Rinse

Active Ingredients

Active Ingredients

Alcohol 8%

Hydrogen Peroxide 0.5%

Menthol 0.15%

Purpose

Purpose

Antigingivitus/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 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

ROYAL WHITENING PRE-BRUSH 
alcohol, hydrogen peroxide, menthol rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73597-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.5 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73597-019-16	499.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/25/2021	01/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/25/2021	01/19/2023

Labeler - Mission Series Inc. dba Prestige Beauty Care (117190866)

Revised: 1/2023

Document Id: f2a5cb86-5603-5cba-e053-2995a90a8c45

34390-5

Set id: b9beb5d8-4f5e-6e08-e053-2995a90a080c

Version: 2

Effective Time: 20230119

 

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