MedPath

Antispetic

Top Care 664.003/664AU Blue Mint Antiseptic Mouthrinse

Approved
Approval ID

a1915524-2719-40d4-86e3-35df5ce3238d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

Topco Associates LLC

DUNS: 006935977

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Eucalyptol, menthol, methyl salicylate, thymol

PRODUCT DETAILS

NDC Product Code36800-664
Application Number505G(a)(3)
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 7, 2025
Generic NameEucalyptol, menthol, methyl salicylate, thymol

INGREDIENTS (12)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
THYMOLActive
Quantity: 0.64 mg in 1 mL
Code: 3J50XA376E
Classification: ACTIB
EUCALYPTOLActive
Quantity: 0.92 mg in 1 mL
Code: RV6J6604TK
Classification: ACTIB
MENTHOLActive
Quantity: 0.42 mg in 1 mL
Code: L7T10EIP3A
Classification: ACTIB
METHYL SALICYLATEActive
Quantity: 0.6 mg in 1 mL
Code: LAV5U5022Y
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

principal display panel

COMPARE TO COOL MINT ®LISTERINE ®ANTISEPTIC MOUTHWASH*

TopCare ®

everyday

Antiseptic

Mouthrinse

ANTIGINVITIS/ANTIPLAQUE

BLUE MINT

  • For better oral hygiene & fresher breath
  • Kills germs that cause bad breath, plaque & the gum disease gingivitis

ADA Accepted

American Dental Association

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

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/27/2025

Use

helps control plaque that leads to gingivitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/27/2025

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO VIJA1024

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

QUALITY GUARANTEED

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

DSP-TN-21091

DSP-MO-20087

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/27/2025

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

WARNINGS SECTION

LOINC: 34071-1Updated: 5/27/2025

Warnings

for this product

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/27/2025

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Cool Mint ®Listerine ® Antiseptic Mouthwash.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/27/2025

Purpose

Antigingivitis, antiplaque

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/27/2025

Do not use

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.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/27/2025

Stop use and ask a dentist if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/27/2025

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/27/2025

Directions

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

Inactive ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/27/2025

Questions?

Call 1-888-423-0139

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Antispetic - FDA Drug Approval Details