FDA.reportPublic FDA data

Antiseptic Mouth Rinse

Manufacturer
WinCo Foods, LLC | Nice-Pak Products, LLC
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:44:15

Label at a glance#

ProductAntiseptic Mouth Rinse
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure14 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 under 12 years of age - consult a dentist or doctor 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°-77°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 under 12 years of age - consult a dentist or doctor

  • 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°-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Questions?

OTC - QUESTIONS SECTION

Call 800-824-1706 Monday - Friday 9am - 4 pm MST

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is manufactued or distributed by Kenvue, INC., distributor of Original LISTERINE ®Antiseptic Mouthwash.

Adverse reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

100% SATISFACTION GUARANTEE

Comments & Questions?

www.wincofoods.com

DSP-TN-21091

DSP-MO-20087

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

*Compare to the active ingredients in Original LISTERINE ®Antiseptic Mouthwash

WinCo ®

FOODS

ANTISEPTIC

Mouth Rinse

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Kills Germs That Cause Bad Breath, Plaque and Gingivitis Gum Disease

For Better Oral Hygiene and Fresher Breath

Original

ADA Accepted

American Dental Association

  • Helps prevent and reduce plaque
  • Helps prevent and reduce gingivitis

1 L (1.05 QT) 33.8 FL OZ

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 % MouthwashPSN15
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD15
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY15

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
67091-106-33Antiseptic Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

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
67091-10667091-106-33

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BENZOIC ACID8SKN0B0MIMIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM BENZOATEOJ245FE5EUIACT
CARAMELT9D99G2B1RIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

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
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC4ad7818e-caee-49f0-81e8-bda6fbd64ea52026-02-12Warnings, Adverse reactionsExact identifier
ndc (package): 67091-106-33
ndc (product): 67091-106
ndc11 (package): 67091010633
spl id: 4aa25068-be77-c8a7-e063-6294a90a1810
spl set id: 4ad7818e-caee-49f0-81e8-bda6fbd64ea5

Reported adverse events (FAERS/openFDA)#

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