Antispetic

Manufacturer
Pharmacy Value Alliance, LLC | Nice-Pak Products, LLC
Effective date
2026-02-05
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
monthly-update
Hydrated at
2026-06-03 17:56:11

Label at a glance#

ProductAntispetic
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 benzoate, FD&C green no.3

Disclaimers

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine Antiseptic mouthwash.

Adverse Reactions

ADVERSE REACTIONS SECTION

If for any reason you are not satisfied 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 YOUR PROTECTION

COMPARE TO COOL MINT LISTERINE ANTSEPTIC MOUTHWASH*

Premier Value ®

Antiseptic

Mouthrinse

Antigingivitis/Antiplaque

blue mint

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

PV

500 mL (16.9 FL OZ)

image descriptionimage descriptionimage descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130840986010309GTIN-13: 0840986010309
EAN-13: 0840986010309
GTIN-12: 840986010309
UPC-A: 840986010309
GTIN storage (14 digits): 00840986010309
mm02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-66468016-664-86, 68016-664-77

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
518c962f-3e4a-bf76-e063-6394a90a3b469e83e4eb-4a74-4646-812e-1d208043e2c42026-05-11Warnings, Adverse reactionsExact identifier
spl set id: 9e83e4eb-4a74-4646-812e-1d208043e2c4

Reported adverse events (FAERS/openFDA)#

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