Antiseptic Mouth Rinse

Manufacturer
GREENBRIER INTERNATIONAL, INC. | Vi-Jon, LLC
Effective date
2023-06-06
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:30:26

Label at a glance#

ProductAntiseptic Mouth Rinse
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure13 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

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

OTC - STOP USE SECTION

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

Keep out of reach of chrildren.

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

OTHER SAFETY INFORMATION

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

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mouthwash.

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Adverse reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

DSP-TN-1500

DSP-MO-34

SDS-TN-15012

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENTS OF LISTERINE*

ASSURED

ORIGINAL

MOUTH

RINSE

ANTISEPTIC

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

16.9 FL OZ (500 mL)

image descriptionimage description

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
33992-031833992-0318-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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
11eada61-6520-854b-e063-6294a90abd9ba48519c2-4434-4e4c-ad2e-476371faf2022024-02-21Warnings, Adverse reactionsExact identifier
spl set id: a48519c2-4434-4e4c-ad2e-476371faf202

Reported adverse events (FAERS/openFDA)#

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