Listerine Cool Mint Antiseptic Mouthwash

SPL v7

SPL

SPL Set ID edb9e374-4dba-5823-e053-2a95a90a3da5

Route

ORAL

Published

Effective Date 2025-03-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (0.6 mg) Thymol (0.64 mg) Eucalyptol (0.92 mg) Menthol (0.42 mg)

Inactive Ingredients

Water Alcohol Poloxamer 407 Benzoic Acid Sorbitol Sodium Benzoate Saccharin Sodium Fd&c Green No. 3

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-21

Description

Drug Facts

Purpose

Antiplaque/antigingivitis

Medication Information

Purpose

Antiplaque/antigingivitis

Description

Drug Facts

Uses

helps prevent and reduce: • plaque • gingivitis

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50570-1

Do not use in children under 12 years of age

Directions

• rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night

• do not swallow

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect)

Ask A Dentist

Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use

Active Ingredient

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Other Information

this rinse is not intended to replace brushing or flossing
store at room temperature
cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive Ingredients

Water, Alcohol (21.6%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3

Principal Display Panel 1 L Bottle Label

ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

LISTERINE ^®

COOL MINT ^®

ANTISEPTIC

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.0 L (1 Qt 1.8 Fl Oz)

Structured Label Content

Uses

helps prevent and reduce: • plaque • gingivitis

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50570-1 (50570-1)

Do not use in children under 12 years of age

Purpose

Antiplaque/antigingivitis

Directions

• rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night

• do not swallow

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect)

Ask A Dentist (Ask a dentist)

Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use

Active Ingredient (Active ingredient)

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Other Information (Other information)

this rinse is not intended to replace brushing or flossing
store at room temperature
cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive Ingredients (Inactive ingredients)

Water, Alcohol (21.6%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3

Principal Display Panel 1 L Bottle Label (PRINCIPAL DISPLAY PANEL - 1 L Bottle Label)

ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

LISTERINE ^®

COOL MINT ^®

ANTISEPTIC

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.0 L (1 Qt 1.8 Fl Oz)

Advanced Ingredient Data

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "0.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "ACTIB", "strengthNumerator": "0.64", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTOL", "unii": "RV6J6604TK", "classCode": "ACTIB", "strengthNumerator": "0.92", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "0.42", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps prevent and reduce: • plaque • gingivitis", "42229-5": "Drug Facts", "50565-1": "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.", "50570-1": "Do not use in children under 12 years of age", "Purpose": "Antiplaque/antigingivitis", "Directions": "• rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night • do not swallow", "Questions?": "call toll-free 888-222-0182 or 215-273-8755 (collect)", "Ask a dentist": "Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use", "Active ingredient": "Eucalyptol 0.092% Menthol 0.042% Methyl Salicylate 0.060% Thymol 0.064%", "Other information": "this rinse is not intended to replace brushing or flossing store at room temperature cold weather may cloud this product. Its antiseptic properties are not affected.", "Inactive ingredients": "Water, Alcohol (21.6%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3", "PRINCIPAL DISPLAY PANEL - 1 L Bottle Label": "ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH LISTERINE ® COOL MINT ® ANTISEPTIC FOR A FRESHER & CLEANER MOUTH THAN BRUSHING ALONE ADA Accepted American Dental Association ® 1.0 L (1 Qt 1.8 Fl Oz)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:40.826407 · Updated: 2026-03-14T23:07:51.764628