FDA.reportPublic FDA data

Crest 3D White

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2019-06-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:20:46

Label at a glance#

ProductCrest 3D White Whitening plus Therapy
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 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 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children’s brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, water, hydrated silica, sodium lauryl sulfate, flavor, trisodium phosphate, cellulose gum, sodium phosphate, sodium saccharin, carbomer.

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

Crest ®

3D WHITE™

NO SLIP

WHITESTRIPS™

DENTAL WHITENING KIT | FLUORIDE ANTI-CAVITY TOOTHPASTE

WHITENING + THERAPY

6 YEARS OF STAIN REMOVAL | STRENGHTHENS ENAMEL

28 STRIPS: 14 TREATMENTS (EACH WITH 1 UPPER/1LOWER); 1TUBE 0.85 OZ (24g) FLUORIDE ANTICAVITY TOOTHPASTE

411411

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
37000-41137000-411-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM PHOSPHATESE337SVY37IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EINGR
WATER059QF0KO0RINGR
POVIDONEFZ989GH94EINGR
HYDROGEN PEROXIDEBBX060AN9VINGR
POLYETHYLENE GLYCOL 400B697894SGQINGR
SACCHARIN SODIUMSB8ZUX40TYINGR
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
8bb32c45-a021-066f-e053-2a95a90ad3d463751e77-51c9-37f0-e053-2991aa0a30e32019-06-19WarningsExact identifier
spl id: 8bb32c45-a021-066f-e053-2a95a90ad3d4
spl set id: 63751e77-51c9-37f0-e053-2991aa0a30e3

Reported adverse events (FAERS/openFDA)#

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