FDA.reportPublic FDA data

Crest 3D White Brilliance

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2019-06-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:20:41

Label at a glance#

ProductCrest 3D White Brilliance Daily Cleansing and Whitening System
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

aids in the prevention of cavities helps prevent gingivitis helps interfere with the harmful effects of plaque associated with gingivitis helps control plaque bacteria that contribute to the development of gingivitis

Dosage and administration

adults and children 12 yrs. of age and 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. of age: ask a dentist

Storage and handling

products containing stannous fluoride may produce surface staining of the teeth adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist see your dentist regularly

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity, antigingivitis toothpaste

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis

Warning

WARNINGS SECTION

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. of age and 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. of age: ask a dentist

Other information

STORAGE AND HANDLING SECTION

  • products containing stannous fluoride may produce surface staining of the teeth
  • adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, mica, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1 (800) 492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRY ME TRIAL SIZE

Crest®

3D WHITE™


FLUORIDE TOOTHPASTE FOR ANTICAVITY &
ANTIGINGIVITIS WHITENING GEL

BRILLIANCE

DEEP CLEANS & KEEPS YOUR SMILE UP TO
99% AS WHITE
AS A PROFESSIONAL POLISH*

DAILY
CLEANSING

WHITENING
SYSTEM

1 TUBE NET WT 0.85 OZ (24 g) &
1 TUBE NET WT 0.68 OZ (19 g)

046046

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-04637000-046-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
ZINC LACTATE2GXR25858YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM HYDROXIDE55X04QC32IIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STANNOUS FLUORIDE3FTR44B32QACTIM
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
HYDROGEN PEROXIDEBBX060AN9VINGR
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDINGR
SUCRALOSE96K6UQ3ZD4INGR
SODIUM HYDROXIDE55X04QC32IINGR

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
8bc63043-c554-f6a4-e053-2a95a90a314d47661f42-6dd9-4d91-e054-00144ff8d46c2019-06-20WarningsExact identifier
spl id: 8bc63043-c554-f6a4-e053-2a95a90a314d
spl set id: 47661f42-6dd9-4d91-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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