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
4
Source
full-release
Hydrated at
2026-06-01 01:47:30

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 ®

INTENSE

ANTIGINGIVITIS

ANTIPLAQUE

MOUTHWASH

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.05%

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6

Other information

SPL UNCLASSIFIED SECTION

  • this rinse is not intended to replace brushing or flossing

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 PROCTER & GAMBLE.

Adverse Reaction

ADVERSE REACTIONS SECTION

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

MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS

QUALITY GUARANTEED

Kroger.com/guarantee

800-632-6900

FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900

DSP-TN-21091 DSP-MO-20087

Principal Panel Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient in CREST ® PRO-HEALTH ® INTENSE CLEAN MINT MOUTHWASH

*See Back Label

Kroger ®

INTENSE

ANTIGINGIVITIS/ANTIPLAQUE

MOUTHWASH

COOLING SENSATION

POWERFUL FRESH MINT

KILLS 99% OF GERMS†

FRESHENS BREATH

HELPS KEEP TEETH CLEAN

PARABEN-FREE

COOLING

HELPS PREVENT PLAQUE & GINGIVITIS 

SUGAR FREE

†Kills at least 99% of many organisms commonly assoicated with bad breath in as little as 15 seconds

QUALITY GUARANTEED

33.8 FL OZ  (1.5 QT) 1 L

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN4
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD4
1251617cetylpyridinium chloride 0.05 % MouthwashSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0021521FBmm01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-953-86Antigingivitis/Antiplaque1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10004

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
59450-95359450-953-86

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
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLOXAMER 407TUF2IVW3M2IACT
SUCRALOSE96K6UQ3ZD4IACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM BENZOATEOJ245FE5EUIACT
CINNAMALDEHYDESR60A3XG0FIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
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.0e61d4a1-0b81-4bca-bdb3-b9927278b7692026-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 59450-953-86
ndc (product): 59450-953
ndc11 (package): 59450095386
spl id: 4bd25cd6-b966-f67a-e063-6394a90addfc
spl set id: 0e61d4a1-0b81-4bca-bdb3-b9927278b769

Reported adverse events (FAERS/openFDA)#

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