Listerine Freshburst Antiseptic

SPL v6

SPL

SPL Set ID ee1e1df9-74c6-d24b-e053-2a95a90a43d3

Route

ORAL

Published

Effective Date 2025-03-04

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 Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Benzoate D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-04-21

Description

Drug Facts

Medication Information

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 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 ingredients	Purposes
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 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)

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% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Flavor, Sodium Benzoate, Yellow 10, Green 3

Principal Display Panel 1 L Bottle Label

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE ^®

FRESHBURST ^®

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 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 ingredients	Purposes
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 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)

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% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Flavor, Sodium Benzoate, Yellow 10, Green 3

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

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE ^®

FRESHBURST ^®

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

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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.", "50569-3": "Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use", "50570-1": "Do not use in children under 12 years of age", "55105-1": "Active ingredients Purposes 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 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)", "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% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Flavor, Sodium Benzoate, Yellow 10, Green 3", "PRINCIPAL DISPLAY PANEL - 1 L Bottle Label": "ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH LISTERINE ® FRESHBURST ® 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: 2026-02-15T12:05:40.827543 · Updated: 2026-03-14T23:07:51.764628