FDA.reportPublic FDA data

Crest Pro-Health

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-07-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:35:21

Label at a glance#

ProductCrest Pro-Health Pro Active Defense Whole Mouth Clean
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

helps prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Dosage and administration

use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use adults and children 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and reduce plaque and gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a dentist if symptoms persist or condition worsens after regular use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
  • adults and children 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
    • do not swallow
    • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, flavor, zinc lactate, methylparaben, sodium saccharin, sucralose, propylparaben, poloxamer 407

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

ALCOHOL FREE

Crest®

PRO-HEALTH™

CPC Antigingivitis/Antiplaque Oral Rinse
PRO/ACTIVE DEFENSE

WHOLE MOUTH CLEAN
Proactively SHEILDS & PROTECTS Against:

Plaque

99% of Germs

Gingivitis

1 L (33.8 FL OZ)

976976

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-97637000-976-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLPARABENZ8IX2SC1OHIACT
POLOXAMER 407TUF2IVW3M2IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ZINC LACTATE2GXR25858YIACT
METHYLPARABENA2I8C7HI9TIACT

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
3ccf9b62-71fe-4f6a-e063-6394a90aab82ab6f757c-a6aa-4508-e053-2995a90a5e882025-08-20WarningsExact identifier
spl set id: ab6f757c-a6aa-4508-e053-2995a90a5e88

Reported adverse events (FAERS/openFDA)#

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