FDA.reportPublic FDA data

Crest 3D White

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:51:31

Label at a glance#

ProductCrest 3D White Deep Clean
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

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

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)

Purpose

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

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, sodium saccharin, carbomer, polysorbate 80, mica, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMPROVED FORMULA

Crest ®
3DWHITE™

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT

4.1 OZ (116 g)
ENAMEL SAFE WHITENING

Removes up to 80% of surface stains

EVEN IN HARD TO REACH PLACES

DEEP CLEAN

944944

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-944-382023-03-31C16284748780-1ba0f9c33-2944-a910-e053-dadaa90a0b85Crest ® 3D White ® Deep Clean
37000-944-412023-03-31C16284748780-1ba0f9c33-2944-a910-e053-dadaa90a0b85Crest ® 3D White ® Deep Clean
37000-944-762023-03-31C16284748780-1ba0f9c33-2944-a910-e053-dadaa90a0b85Crest ® 3D White ® Deep Clean
37000-944-822023-03-31C16284748780-1ba0f9c33-2944-a910-e053-dadaa90a0b85Crest ® 3D White ® Deep Clean
37000-944-412021-02-12C16284748780-1ba0f9c33-2944-a910-e053-dadaa90a0b85Crest ® 3D White ® Deep Clean
37000-944-822021-02-12C16284748780-1ba0f9c33-2944-a910-e053-dadaa90a0b85Crest ® 3D White ® Deep Clean
37000-944-412021-01-29C16284748780-1ba0f9c33-2944-a910-e053-dadaa90a0b85Crest ® 3D White ® Deep Clean
37000-944-822021-01-29C16284748780-1ba0f9c33-2944-a910-e053-dadaa90a0b85Crest ® 3D White ® Deep Clean

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-944CREST 3D WHITE DEEP CLEAN (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Legacy NDC20250110_9622886f-5c58-1c72-e053-2a95a90a9aa9.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-94437000-944-41, 37000-944-82, 37000-944-38, 37000-944-76

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM HYDROXIDE55X04QC32IIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POLYSORBATE 806OZP39ZG8HIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
40bd923b-50f7-c9dd-e063-6294a90a71f39622886f-5c58-1c72-e053-2a95a90a9aa92025-10-09WarningsExact identifier
spl set id: 9622886f-5c58-1c72-e053-2a95a90a9aa9

Reported adverse events (FAERS/openFDA)#

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