MedPath

Crest

Crest 3D White Brilliance Luminous Purple

Approved
Approval ID

fbfcd837-4d88-5f82-e053-6394a90afbf6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 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 Code69423-787
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (18)

FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Code: P1BM4ZH95L
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1.6 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

LARGE SIZE

CREST

3D WHITE

BRILLIANCE

LUMINOUS PURPLE

EXTRA STRENGTH WHITENING

net wt 4.6 oz (130 g)

FLUORIDE ANTICAVITY TOOTHPASTE

ENAMEL SAFE

WHITER TEETH IN 3 DAYS

Artwork

INDICATIONS & USAGE SECTION

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

Use

helps protect against cavities

OTC - QUESTIONS SECTION

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

Questions?

1-800-492-7378

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% (0.15% w/v fluoride ion)

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.

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: 6/15/2022

Inactive ingredients

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, sodium
lauryl sulfate, cocamidopropyl betaine, trisodium phosphate, sodium saccharin, PVP, carrageenan, xanthan gum, sucralose, mica, titanium dioxide, red 40, blue 1

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