FDA.reportPublic FDA data

Crest Scope

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:43:12

Label at a glance#

ProductCrest Scope Advanced
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 6 years & older: Use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL (2teaspoonfuls) of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years & older: Use twice a day after brushing your teeth with a toothpaste.
  • Vigorously swish 10 mL (2teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
  • Do not swallow the rinse.
  • Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (15 wt%), propylene glycol, flavor, benzoic acid, poloxamer 407, cetylpyridinium chloride, sucralose, phosphoric acid, disodium phosphate, yellow 5, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-862-7442

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 1000mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest®
ANTICAVITY FLUORIDE MOUTHWASH
scope®

ADVANCED™

MULTI-ACTION FORMULA

+FLOURIDE

  • HELPS PREVENT CAVITIES
  • FORTIFIES ENAMEL
  • FRESHENS BREATH
  • CLEANS WHOLE MOUTH

IMPORTANT: Read directions for proper use.
SEE BACK FOR IMPORTANT INGREDIENT INFORMATION.

1L (33.8 FL OZ)

LABELSLABELS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-208-052023-05-31C16284748780-1ba0f9c33-2e8c-a910-e053-dadaa90a0b85Crest ® Scope® Advanced™
37000-208-102023-05-31C16284748780-1ba0f9c33-2e8c-a910-e053-dadaa90a0b85Crest ® Scope® Advanced™
37000-208-052021-02-12C16284748780-1ba0f9c33-2e8c-a910-e053-dadaa90a0b85Crest ® Scope® Advanced™
37000-208-102021-02-12C16284748780-1ba0f9c33-2e8c-a910-e053-dadaa90a0b85Crest ® Scope® Advanced™
37000-208-052021-01-29C16284748780-1ba0f9c33-2e8c-a910-e053-dadaa90a0b85Crest ® Scope® Advanced™
37000-208-102021-01-29C16284748780-1ba0f9c33-2e8c-a910-e053-dadaa90a0b85Crest ® Scope® Advanced™

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-20837000-208-05, 37000-208-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 5I753WB2F1MIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PHOSPHORIC ACIDE4GA8884NNIACT
ALCOHOL3K9958V90MIACT
BENZOIC ACID8SKN0B0MIMIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2bb0caae-5be4-3f0f-e063-6294a90a896a81141f59-21d8-c8b0-e053-2a91aa0a4c562025-01-14WarningsExact identifier
spl set id: 81141f59-21d8-c8b0-e053-2a91aa0a4c56

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.