FDA.reportPublic FDA data

Oral B Plaque Defense

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
monthly-update
Hydrated at
2026-06-03 17:51:50

Label at a glance#

ProductOral B Plaque Defense Special Care Oral Rinse
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

Warning

WARNINGS SECTION

WARNINGS 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 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

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

Questions?

OTC - QUESTIONS SECTION

1-800-566-7252

SPL UNCLASSIFIED SECTION

DISTR. BY ORAL-B, A DIVISION

OF PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral-B

CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

GUM DETOXIFY

SPECIAL CARE ORAL RINSE

24-HOUR

Gingivitis Protection*

  • Helps reverse early signs of gum disease
  • Kills plaque bacteria around the gumline
  • Reduces guminflammation & bleeding

475 mL (16 FL OZ)

Oral-B Plaque Defense Special Care Oral RinseOral-B Plaque Defense Special Care Oral Rinse

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN9
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD9
1100924cetylpyridinium chloride 0.07 % Oral RinseSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-855-16Oral B Plaque DefenseSpecial Care Oral Rinse475 mL in 1 BOTTLE, PLASTICRINSE4759

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
69423-85569423-855-16

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
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLOXAMER 407TUF2IVW3M2IACT
SUCRALOSE96K6UQ3ZD4IACT
ZINC LACTATE2GXR25858YIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-07-31full-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
Oral B Plaque Defense Special Care Oral RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd503fad5-a378-0e60-e053-2a95a90abe652026-01-08WarningsExact identifier
ndc (package): 69423-855-16
ndc (product): 69423-855
ndc11 (package): 69423085516
spl id: 47e46668-d67a-0d37-e063-6394a90a7dc4
spl set id: d503fad5-a378-0e60-e053-2a95a90abe65

Reported adverse events (FAERS/openFDA)#

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