FDA.reportPublic FDA data

Crest Complete Plus Scope

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-01-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:38

Label at a glance#

ProductCrest Complete Plus Scope Intense Freshness
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

Adults and children 6 years & older: • Use twice a day after brushing your teeth with a toothpaste. • Vigorously swish 10 mL (2 teaspoonfuls) 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 capa...

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

Uses

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 (2 teaspoonfuls) 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 (14.25 wt%), propylene glycol, flavor, benzoic acid, poloxamer
407, cetylpyridinium chloride, sucralose, phosphoric acid, disodium phosphate, yellow 5, blue 1

Questions?

OTC - QUESTIONS SECTION

1–800–285–9139

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+FLUORIDE

Crest

complete

plus Scope

ANTICAVITY FLUORIDE

MOUTHWASH

ANTI-CAVITY

+

INTENSE FRESHNESS

IMPORTANT: Read

directions for proper use.

SEE BACK FOR

IMPORTANT

INGREDIENT

INFORMATION

FRESH MINT

1L (33.8 FL OZ)

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-709CREST COMPLETE PLUS SCOPE INTENSE FRESHNESS (SODIUM FLUORIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Unmatched20250116_16509819-efb2-ebc2-e063-6294a90a59e0.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-70969423-709-33, 69423-709-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
PHOSPHORIC ACIDE4GA8884NNIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SUCRALOSE96K6UQ3ZD4IACT

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
47e52638-7028-9c62-e063-6294a90a965f16509819-efb2-ebc2-e063-6294a90a59e02026-01-08WarningsExact identifier
spl set id: 16509819-efb2-ebc2-e063-6294a90a59e0

Reported adverse events (FAERS/openFDA)#

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