FDA.reportPublic FDA data

Crest 3D White

Manufacturer
Procter & Gamble Manufacturing México, S. de R.L. de C.V.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:51:55

Label at a glance#

ProductCrest 3D White Stain Eraser Icy Clean Mint
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 - 99 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest ®

3D WHITE™
FLUORIDE ANTICAVITY TOOTHPASTE

NET WT
3.5 OZ (99 g)
ENAMEL SAFE WHITENING

STAIN ERASER

ICY CLEAN MINT

Cleans Away Stubborn Stains including:

COFFEE SODA TEA WINE

932932

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN6
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD6
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY6
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58933-932-352023-02-14C16284748780-1ba0f9c33-4620-a910-e053-dadaa90a0b85Crest ® 3D White™ Stain Eraser Icy Clean Mint
58933-932-352023-02-14C16284748780-1ba0f9c33-4620-a910-e053-dadaa90a0b85Crest ® 3D White™ Stain Eraser Icy Clean Mint
58933-932-352023-01-30C16284748780-1ba0f9c33-4620-a910-e053-dadaa90a0b85Crest ® 3D White™ Stain Eraser Icy Clean Mint
58933-932-352023-01-30C16284748780-1ba0f9c33-4620-a910-e053-dadaa90a0b85Crest ® 3D White™ Stain Eraser Icy Clean Mint
58933-932-352021-06-10C16284748780-1ba0f9c33-4620-a910-e053-dadaa90a0b85Crest ® 3D White™ Stain Eraser Icy Clean Mint
58933-932-352021-06-10C16284748780-1ba0f9c33-4620-a910-e053-dadaa90a0b85Crest ® 3D White™ Stain Eraser Icy Clean Mint
58933-932-352021-01-29C16284748780-1ba0f9c33-4620-a910-e053-dadaa90a0b85Crest ® 3D White™ Stain Eraser Icy Clean Mint
58933-932-352021-01-29C16284748780-1ba0f9c33-4620-a910-e053-dadaa90a0b85Crest ® 3D White™ Stain Eraser Icy Clean Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-932-35Crest 3D WhiteStain Eraser Icy Clean Mint99 g in 1 TUBEPASTE, DENTIFRICE996
58933-932-35Crest 3D WhiteStain Eraser Icy Clean Mint1 in 1 CARTONPASTE, DENTIFRICE16

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
58933-93258933-932-35

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
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-08-13full-release2026-06-01 01:10:24

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
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.8de12c9f-eb16-aa26-e053-2a95a90a1b9c2026-01-08WarningsExact identifier
ndc (package): 58933-932-35
ndc (product): 58933-932
ndc11 (package): 58933093235
spl id: 47e560c6-bd21-1264-e063-6394a90a0048
spl set id: 8de12c9f-eb16-aa26-e053-2a95a90a1b9c

Reported adverse events (FAERS/openFDA)#

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