MedPath

Antiseptic

Good Sense 318.003/318AH-AI Antiseptic Mouthrinse

Approved
Approval ID

50776776-80aa-4098-8cf3-6daa0b305b15

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Perrigo Direct, Inc.

DUNS: 076059836

Products 1

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

Eucayptol, menthol, methyl salicylate, thymol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50804-318
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Eucayptol, menthol, methyl salicylate, thymol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (10)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
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
THYMOLActive
Quantity: 0.64 mg in 1 mL
Code: 3J50XA376E
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/26/2025

Principal display panel

Sealed With Printed Neckband For Your Protection

GoodSense ®

NDC 50804-318-86

Antiseptic

Mouth Rinse

Original

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

Compare to active ingredients of Listerine ®*

1 Liter (1.05 QT) 33.8 FL OZ

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/26/2025

Use

helps control plaque that leads to gingivitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/26/2025

ADVERSE REACTION

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

GoodSense ®is a registered trademark of L. Perrigo Company.

DSP-TN-21091

DSP-MO-20087

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/26/2025

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl saliclate 0.060%

Thymol 0.064%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/26/2025

Purpose

Antigingivitis, Antiplaque

WARNINGS SECTION

LOINC: 34071-1Updated: 8/26/2025

Warnings

for this product ​

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/26/2025

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 serous form of gum disease.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/26/2025

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: 8/26/2025

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: 8/26/2025

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsfuls) 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 SECTION

LOINC: 44425-7Updated: 8/26/2025

Other information

cold weather may cloud this product. Its antiseptic properties are not affected.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/26/2025

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/26/2025

Disclaimer

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

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