FDA.reportPublic FDA data

Crest Pro-Health

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:21

Label at a glance#

ProductCrest Pro-Health Gum Care
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, propylene glycol, flavor, poloxamer 407, methylparaben, propylparaben, sodium saccharin, yellow 6, green 3

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®

Pro Health

CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

GUM CARE

NEUTRALIZES PLAQUE GERMS

AROUND THE GUM LINE

COOL WINTERGREEN

• 24 HR Protection*

• Helps prevent and reduce gingivitis

+ Alcohol Free

1 L

(33.8 FL OZ)

Crest Pro Health Gum CareCrest Pro Health Gum Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-864-16Crest Pro-HealthGum Care500 mL in 1 BOTTLE, PLASTICRINSE5007
69423-864-33Crest Pro-HealthGum Care1000 mL in 1 BOTTLE, PLASTICRINSE10007
69423-864-67Crest Pro-HealthGum Care1000 mL in 1 BOTTLERINSE10007
69423-864-67Crest Pro-HealthGum Care2 in 1 CELLO PACKRINSE27

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
69423-86469423-864-33, 69423-864-16, 69423-864-67

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
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C GREEN NO. 33P3ONR6O1SIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-07-31full-release2026-06-01 01:09:06

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
Crest Pro-Health Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd721e2cb-8f67-3d07-e053-2995a90ae65a2026-01-08WarningsExact identifier
ndc (package): 69423-864-33
ndc (package): 69423-864-67
ndc (package): 69423-864-16
ndc (product): 69423-864
ndc11 (package): 69423086416
ndc11 (package): 69423086467
ndc11 (package): 69423086433
spl id: 47e495e8-478b-b045-e063-6294a90a438e
spl set id: d721e2cb-8f67-3d07-e053-2995a90ae65a

Reported adverse events (FAERS/openFDA)#

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