CREST 3D WHITE BRILLIANCE ADVANCED WHITENING FRESH MINT- sodium monofluorophosphate paste, dentifrice

Crest 3D White Brilliance by

Drug Labeling and Warnings

Crest 3D White Brilliance by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Sodium monofluorophosphate 1.14%

(0.17% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

WARNINGS

Warning

Keep out of reach of children under 12 yrs. 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 12 yrs. & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
• do not swallow
• children under 12 yrs.: ask a dentist

Inactive ingredients

water, calcium pyrophosphate, glycerin, hydrogen peroxide (4% w/v), sodium lauryl sulfate, flavor, polyacrylate crosspolymer-6, cetearyl alcohol, disodium pyrophosphate, sucralose, tetrasodium pyrophosphate

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

85g tube in carton

4% HYDROGEN PEROXIDE

Crest®

3DWHITE™

BRILLIANCE™

FLUORIDE ANTICAVITY TOOTHPASTE

HYDROGEN PEROXIDE

Highest Level of Hydrogen Peroxide in Toothpaste

ADVANCED WHITENING TO REMOVE SURFACE STAINS AND DEEPLY CLEAN

FRESH MINT

NET WT 3.0 OZ (85 g)

INGREDIENTS AND APPEARANCE

CREST 3D WHITE BRILLIANCE  ADVANCED WHITENING FRESH MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-959
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-959-30	1 in 1 CARTON	07/28/2021
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69423-959-03	3 in 1 CELLO PACK	07/28/2021
2		1 in 1 CARTON
2		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/28/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)