FDA.reportPublic FDA data

Crest Pure

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:13

Label at a glance#

ProductCrest Pure
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 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 supervis...

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

Warning

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 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, propylene glycol, poloxamer 407, polysorbate 80, benzoic acid, flavor, sucralose, sodium benzoate, phosphoric acid, disodium phosphate

Questions?

OTC - QUESTIONS SECTION

1-800-285-9139

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest®

ANTICAVITY FLUORIDE RINSE

TRUSTED PROTECTION

FIGHTS CAVITIES & FRESHENS BREATH

IMPORTANT: Read directions for proper use.

made without:

alcohol

artificial dyes

sodium lauryl sulfate (SLS)

gluten

MINT

1 L (33.8 FL OZ)

6942394169423941

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-94169423-941-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZOIC ACID8SKN0B0MIMIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SODIUM BENZOATEOJ245FE5EUIACT
POLYSORBATE 806OZP39ZG8HIACT
POLOXAMER 407TUF2IVW3M2IACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
075e426f-aee9-1f7f-e063-6294a90a6661c68b157b-77f9-287c-e053-2a95a90a73ce2023-10-10WarningsExact identifier
spl set id: c68b157b-77f9-287c-e053-2a95a90a73ce

Reported adverse events (FAERS/openFDA)#

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