Listerine ®

Listerine ®
SPL v9
SPL
SPL Set ID 62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8
Route
ORAL
Published
Effective Date 2022-10-11
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 2018-08-17 Until 2023-10-11

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

helps prevent and reduce:

  • plaque
  • gingivitis
Section 42229-5

Drug Facts

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

Keep Out of Reach of Children.

​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.

Principal Display Panel 1500 Ml Bottle Label

ANTISEPTIC

LISTERINE ®

FRESHBURST ®

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.5 L (1 Qt 1 Pt 2.7 fl oz)


Structured Label Content

Uses

helps prevent and reduce:

  • plaque
  • gingivitis
Section 42229-5 (42229-5)

Drug Facts

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

Keep Out of Reach of Children. (Keep out of reach of children.)

​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.

Principal Display Panel 1500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label)

ANTISEPTIC

LISTERINE ®

FRESHBURST ®

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.5 L (1 Qt 1 Pt 2.7 fl oz)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)