FDA.reportPublic FDA data

Antigingivitis/Antiplaque

Manufacturer
The Kroger Co. | Nice-Pak Products, LLC
Effective date
2026-02-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:47:57

Label at a glance#

ProductAntigingivitis/Antiplaque
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure15 sections

Dosage and administration

adults and children 6 years & 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 when used after brushing, rinse mouth with water first children under 6 years of age: do not use

Label contents#

Full prescribing information#

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Claims

SPL UNCLASSIFIED SECTION

Kroger ®

GUM DEFENSE

ANTIGINGIVITIS 

ANTIPLAQUE

MOUTH RINSE

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque that leads to gingivitis

Warnings

WARNINGS SECTION

For this product

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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: 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
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-632-6900

Disclaimers

SPL UNCLASSIFIED SECTION

This may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

*Crest ® and Pro-Health ® are registered trademarks of the Proctor & Gamble Co.

ADVERSE REACTION

ADVERSE REACTIONS SECTION

PROUDLY DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202

MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS.

Quality Guaranteed

Kroger.com/guarantee   800-632-6900 

Principal Panel Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TOCREST ®PRO-HEALTH ® BREATHPURIFY AND GUM CARE ORAL RINSE

SEE BACK LABEL*

Kroger ®

GUM DEFENSE

ANTIGINGIVITIS • ANTIPLAQUE

MOUTH RINSE

ALCOHOL-FREE

SMOOTH MINT

KILLS GERMS THAT CAUSE BAD BREATH

HELPS DEFEND AGAINST EARLY SIGNS OF GUM DISEASE

HELPS IMPROVE GUM HYGIENE

QUALITY GUARANTEED

33.8 FL OZ (1.05 QT) 1 L

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN5
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD5
1100924cetylpyridinium chloride 0.07 % Oral RinseSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0020614FBmm01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-997-86Antigingivitis/Antiplaque1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10005

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59450-99759450-997-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ZINC LACTATE2GXR25858YIACT
BENZOIC ACID8SKN0B0MIMIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM BENZOATEOJ245FE5EUIACT
POLOXAMER 407TUF2IVW3M2IACT
CINNAMALDEHYDESR60A3XG0FIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

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
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDEThe Kroger Co.922bff32-7536-4a6d-b04b-0b02f14fbecc2026-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 59450-997-86
ndc (product): 59450-997
ndc11 (package): 59450099786
spl id: 4bd21344-e34f-9f71-e063-6294a90aec5b
spl set id: 922bff32-7536-4a6d-b04b-0b02f14fbecc

Reported adverse events (FAERS/openFDA)#

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