FDA.reportPublic FDA data

Antispetic

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:44:05

Label at a glance#

ProductAntispetic
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 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY

TOPCO ASSOCIATES, LLC

ITASCA, IL 60143

©TOPCO VIJA1024

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

DSP-TN-21091

DSP-MO-20087

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ®

everyday

DYE FREE

Antiseptic

Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

REFRESHING MINT

  • Kills 99% of germs commonly associated with gingivitis
  • Freshens breath
  • With essential oils
  • Sugar free

33.8 FL OZ (1QT 1.8 FL OZ) 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 % MouthwashPSN7
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD7
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-567-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10007

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
76162-56776162-567-86

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
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB
WATER059QF0KO0RIACT

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
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLC24b19a98-143d-4634-b2b3-4d02dfd579872026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 76162-567-86
ndc (product): 76162-567
ndc11 (package): 76162056786
spl id: 4ab96880-299b-1565-e063-6294a90ae716
spl set id: 24b19a98-143d-4634-b2b3-4d02dfd57987

Reported adverse events (FAERS/openFDA)#

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