Anitseptic Mouth Rinse

Manufacturer
Pharmacy Value Alliance LLC | Consumer Product Partners, LLC
Effective date
2025-03-10
Label type
HUMAN OTC DRUG LABEL
Version
19
Source
legacy-cache
Hydrated at
2026-08-01 20:40:37

Label at a glance#

ProductAnitseptic 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 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 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 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no.10, FD&C green no.3

Questions?

OTC - QUESTIONS SECTION

1-888-593-0593

ADVERSE REACTION

ADVERSE REACTIONS SECTION

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

If for any reason you are not satisified with this product, please return it to the store where purchased for a full refund.

Distributed by:

Pharmacy Value Alliance LLC

407 East Lancaster Avenue,

Wayne, PA 19087

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR Y0UR PROTECTION

COMPARE TO FRESHBURST LISTERINE ANTISEPTIC MOUTHWASH*

Premier Value®

Antiseptic 

Mouthrinse

Antigingivitis/Antiplaque

spring mint®

kills germs that cause bad breath, plaque & the gum disease gingivitis

1 L (33.8 FL OZ)

image descriptionimage descriptionimage descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-941ANITSEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [PHARMACY VALUE ALLIANCE LLC]19Legacy NDC20250312_6d611caa-b382-48f9-b954-8ea5cf198aa2.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-94168016-941-77

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
48c20dcc-72d6-0ede-e063-6294a90a3b596d611caa-b382-48f9-b954-8ea5cf198aa22026-01-19Warnings, Adverse reactionsExact identifier
spl set id: 6d611caa-b382-48f9-b954-8ea5cf198aa2

Reported adverse events (FAERS/openFDA)#

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