Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash

SPL v1

SPL

SPL Set ID 456d45e8-bf6d-31c4-e063-6394a90a5c00

Route

ORAL

Published

Effective Date 2025-12-08

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 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-19

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

Warnings

Warnings

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 (26.9% v/v), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel

Principal Display Panel 1 L Bottle Label

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE®

ORIGINAL

ANTISEPTIC

FRESH &

CLEAN

KILLS 99.9% OF GERMS*

*THAT CAUSE BAD BREATH,

PLAQUE & GINGIVITIS

1.0 L (1 Qt 1.8FL 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

Warnings

Warnings

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 (26.9% v/v), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel

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

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE®

ORIGINAL

ANTISEPTIC

FRESH &

CLEAN

KILLS 99.9% OF GERMS*

*THAT CAUSE BAD BREATH,

PLAQUE & GINGIVITIS

1.0 L (1 Qt 1.8FL 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": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARAMEL", "unii": "T9D99G2B1R", "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", "Warnings": "Warnings", "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 (26.9% v/v), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel", "PRINCIPAL DISPLAY PANEL - 1 L Bottle Label": "ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH LISTERINE® ORIGINAL ANTISEPTIC POWERED BY ESSENTIAL OILS FRESH & CLEAN KILLS 99.9% OF GERMS* *THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS 1.0 L (1 Qt 1.8FL Oz)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:45.798255 · Updated: 2026-03-14T23:11:32.027299