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Crest 3D White

Crest 3D White™ Fresh Mint

Approved
Approval ID

01f27a63-15f3-cee4-e063-6394a90afa3b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Procter & Gamble Manufactura, S. de R.L. de C.V.

DUNS: 812807550

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58933-881
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (14)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CARBOXYPOLYMETHYLENEInactive
Code: 0A5MM307FC
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1.5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SODIUM ACID PYROPHOSPHATEInactive
Code: H5WVD9LZUD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/26/2016

PRINCIPAL DISPLAY PANEL - 65 g Tube Carton

Crest®

3D WHITE™

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT

2.3 OZ (65 g)

ENAMEL SAFE WHITENING

STAIN ERASER

FRESH MINT

CLEANS AWAY STUBBORN STAINS INCLUDING:

COFFEE, SODA, TEA, WINE

artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/26/2016

Use

helps protect against cavities

WARNINGS SECTION

LOINC: 34071-1Updated: 1/26/2016

Warning

**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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/26/2016

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/26/2016

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/26/2016

Purpose

Anticavity toothpaste

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/26/2016

Directions

  • 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 1/26/2016

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/26/2016

Questions?

1-800-492-7378

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