FDA.reportPublic FDA data

Crest 3D White

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-02-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:41:02

Label at a glance#

ProductCrest 3D White Brilliance Hydrogen Peroxide
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 1.14%

(0.17% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

Crest 3D White Ultra White 85g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% HYDROGEN PEROXIDE

Crest

3D WHITE

BRILLIANCE

FLUORIDE ANTICAVITY

TOOTHPASTE

HYDROGEN

PEROXIDE

Highest Level of

Hydrogen Peroxide

in Toothpaste

ADVANCED WHITENING

TO REMOVE SURFACE STAIN

AND DEEPLY CLEAN

FRESH MINT

NET WT 3.0 OZ (85 g)

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-604CREST 3D WHITE BRILLIANCE HYDROGEN PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Unmatched20250227_23075ae0-71ba-148f-e063-6394a90aea30.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-60484126-604-30, 84126-604-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
CALCIUM PYROPHOSPHATEX69NU20D19IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
47ba9bd1-bc00-3932-e063-6294a90afd3a23075ae0-71ba-148f-e063-6394a90aea302026-01-06Exact identifier
spl set id: 23075ae0-71ba-148f-e063-6394a90aea30

Reported adverse events (FAERS/openFDA)#

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