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Crest Premium Plus

Crest Premium Plus Scope Outlast Active Foam

Approved
Approval ID

b789587e-7f49-163a-e053-2a95a90a823f

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 Code37000-991
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 (20)

POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
CARBOXYPOLYMETHYLENEInactive
Code: 0A5MM307FC
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CETYLPYRIDINIUM CHLORIDEInactive
Code: D9OM4SK49P
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM ACID PYROPHOSPHATEInactive
Code: H5WVD9LZUD
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
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: 12/28/2020

PRINCIPAL DISPLAY PANEL - 204 g Tube Carton

Crest

plus

PREMIUM

NET WT 7.2OZ (204 g)

ANTICAVITY FLUORIDE TOOTHPASTE

ACTIVE FOAM

+WHITENING
scope ®
OUTLAST®

KILLS UP TO 99.9% OF BAD BREATH GERMS*

long lasting mint

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/14/2012

Use

helps protect against cavities

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/14/2012

Dist. by Procter & Gamble,Cincinnati, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/14/2012

Active ingredient

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/14/2012

Purpose

Anticavity toothpaste

WARNINGS SECTION

LOINC: 34071-1Updated: 3/14/2012

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: 3/14/2012

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/28/2020

Inactive ingredients

sorbitol, water, hydrated silica, disodium pyrophosphate, flavor, sodium lauryl sulfate, sodium hydroxide, alcohol (0.7%), sodium saccharin, xanthan gum, glycerin, poloxamer 407, carbomer, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/14/2012

Questions?

1-800-492-7378

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Crest Premium Plus - FDA Drug Approval Details