MedPath

Crest Plus

Crest Plus Cinnamon Expressions + Whitening

Approved
Approval ID

151d2a0a-448f-7744-e063-6294a90acd3b

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 Code69423-840
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 (12)

CARBOXYPOLYMETHYLENEInactive
Code: 0A5MM307FC
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1.5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2024

PRINCIPAL DISPLAY PANEL - 153 g Tube Carton

Crest®

plus

ANTICAVITY FLUORIDE TOOTHPASTE

NET WT 5.4 OZ (153g)

+ WHITENING

CINNAMON EXPRESSIONS

cinnamon rush

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/10/2012

Use

helps protect against cavities

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/29/2019

Inactive ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, flavor, trisodium phosphate, cellulose gum, sodium phosphate, sodium saccharin, carbomer, polysorbate 80, red 40

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/10/2012

Questions?

1-800-285-3213

SPL UNCLASSIFIED SECTION

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

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/29/2019

Active ingredient

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/10/2012

Purpose

Anticavity toothpaste

WARNINGS SECTION

LOINC: 34071-1Updated: 1/10/2012

Warnings

**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: 1/10/2012

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

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Crest Plus - FDA Drug Approval Details