FDA.reportPublic FDA data

Mouth Rinse

Manufacturer
The Kroger Co. | Nice-Pak Products, LLC
Effective date
2026-02-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:48:11

Label at a glance#

ProductMouth Rinse
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure12 sections

Dosage and administration

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow  children 6 years to under 12 years of age - supervise use children under 6 years of age - do not use this rinse is not intended to replace brushing or flossing

Storage and handling

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59° to 86°F).

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque that leads to gingivitis

Warnings

WARNINGS SECTION

for this product

Do not use

OTC - DO NOT USE SECTION

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

OTC - STOP USE SECTION

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of children.

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 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow 

children 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

  • this rinse is not intended to replace brushing or flossing

Other information

STORAGE AND HANDLING SECTION

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59° to 86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (21.6% v/v), sorbitol, capryl/capramidopropyl betaine, flavor, benzoic acid, Stevia rebaudiana leaf extract, sodium benzoate

ADVERSE REACTION

ADVERSE REACTIONS SECTION

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

For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900

*Check out simpletruth.com for full list

We Guarantee Quality.

simpletruth.com/guarantee

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

PLEASE RECYCLE

DSP-TN-21091

DSP-MO-20087

Principal Panel Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

simple truth ®

FREE FROM* 

UNWANTED INGREDIENTS

NO Artificial Sweetners

NO Added Dyes

Breath & Gum Cleanser

ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

HERBAL MINT WITH ESSENTIAL OILS

Fights Bad Breath

Helps Prevent Plaque & Gingivitis

PHTHALATES & SULFATES FREE

NO POLY-ETHYLENE GLYCOL

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
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN6
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD6
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY6

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
59450-901-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10006

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59450-90159450-901-86

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
SORBITOL506T60A25RIACT
CAPRYL/CAPRAMIDOPROPYL BETAINE231H3ZT9NEIACT
BENZOIC ACID8SKN0B0MIMIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SODIUM BENZOATEOJ245FE5EUIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-01-20monthly-update2026-06-03 17:53:00

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
Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e2026-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 59450-901-86
ndc (product): 59450-901
ndc11 (package): 59450090186
spl id: 4bd2154d-e552-b55c-e063-6394a90a88ec
spl set id: f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e

Reported adverse events (FAERS/openFDA)#

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