Listerine ®

Listerine ®
SPL v11
SPL
SPL Set ID 78e2e172-09a4-4bf1-9871-d099c49087be
Route
ORAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol, Unspecified Form (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Benzoic Acid Poloxamer 407 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-01-06 Until 2021-10-07
Description

Drug Facts

Medication Information

Description

Drug Facts

Use

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 50569-3

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

Section 50570-1

Do not use in children under 12 years of age

Section 55105-1
Active ingredient Purpose
Eucalyptol (0.092%) Antiplaque/antigingivitis
Menthol (0.042%) Antiplaque/antigingivitis
Methyl Salicylate (0.060%) Antiplaque/antigingivitis
Thymol (0.064%) Antiplaque/antigingivitis
Directions
  • rinse full strength for 30 seconds with 20mL (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)

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 1.0 L Bottle Label

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE®

ORIGINAL

ANTISEPTIC

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

1.0 L (1 Qt 1.8 Fl Oz)

Structured Label Content

Use

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 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use in children under 12 years of age

Section 55105-1 (55105-1)
Active ingredient Purpose
Eucalyptol (0.092%) Antiplaque/antigingivitis
Menthol (0.042%) Antiplaque/antigingivitis
Methyl Salicylate (0.060%) Antiplaque/antigingivitis
Thymol (0.064%) Antiplaque/antigingivitis
Directions
  • rinse full strength for 30 seconds with 20mL (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)

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 1.0 L Bottle Label (PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label)

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE®

ORIGINAL

ANTISEPTIC

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

1.0 L (1 Qt 1.8 Fl Oz)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:40.808017 · Updated: 2026-03-14T23:07:51.764628