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Crest 3D White

Crest 3D White Advanced Glamorous White

Approved
Approval ID

f5b18988-68c7-40f9-e053-2995a90a22bc

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

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 Code69423-768
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (14)

MICAInactive
Code: V8A1AW0880
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM SACCHARINInactive
Code: SB8ZUX40TY
Classification: IACT
CELLULOSE GUMInactive
Code: K679OBS311
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DISODIUM PYROPHOSPHATEInactive
Code: H5WVD9LZUD
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1.6 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/1/2025

PRINCIPAL DISPLAY PANEL - 93 g Tube Carton

CREST

3D WHITE

ADVANCED

GLAMOROUS WHITE

DAILY WHITENING UPKEEP

WHITER TEETH IN 5 DAYS

NET WT 3.3 OZ (92 g)

FLUORIDE ANTICAVITY TOOTHPASTE

ENAMEL SAFE

Artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/11/2014

Use

helps protect against cavities

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/11/2014

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: 6/4/2021

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 10/29/2019

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/11/2014

Active ingredient

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/11/2014

Questions?

1-800-492-7378

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/11/2014

Purpose

Anticavity toothpaste

WARNINGS SECTION

LOINC: 34071-1Updated: 2/11/2014

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.

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