FDA.reportPublic FDA data

Crest

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
monthly-update
Hydrated at
2026-06-03 17:52:01

Label at a glance#

ProductCrest Gum Care
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 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

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

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.

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

1–800–862-7442

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest®
CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL MOUTHWASH

GUM CARE

Neutralizes Plaque Germs Around the Gum Line
COOL WINTERGREEN

1 L(33.8 FL OZ)

576576

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-576-01CrestGum Care1000 mL in 1 BOTTLE, PLASTICRINSE100010
37000-576-05CrestGum Care500 mL in 1 BOTTLE, PLASTICRINSE50010
37000-576-21CrestGum Care1000 mL in 1 BOTTLE, PLASTICRINSE100010
37000-576-21CrestGum Care2 in 1 CELLO PACKRINSE210

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
37000-57637000-576-01, 37000-576-05, 37000-576-21

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-10-09monthly-update2026-06-03 17:39:11
82025-08-06full-release2026-06-01 01:09:41

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 Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company72f1a02f-1d02-7e83-e053-2a91aa0a79472026-01-08WarningsExact identifier
ndc (package): 37000-576-21
ndc (package): 37000-576-01
ndc (package): 37000-576-05
ndc (product): 37000-576
ndc11 (package): 37000057601
ndc11 (package): 37000057621
ndc11 (package): 37000057605
spl id: 47e4bcee-5029-eff8-e063-6294a90a9a3c
spl set id: 72f1a02f-1d02-7e83-e053-2a91aa0a7947

Reported adverse events (FAERS/openFDA)#

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