LISTERINE COOL MINT ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Listerine Cool Mint Antiseptic by

Drug Labeling and Warnings

Listerine Cool Mint Antiseptic by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Purpose

Antiplaque/antigingivitis

Uses

helps prevent and reduce: plaque gingivitis

Warnings

Do not use in children under 12 years of age

Ask a dentist

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

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.

Directions

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

do not swallow

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

Questions?

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

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Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

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)

INGREDIENTS AND APPEARANCE

LISTERINE COOL MINT ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0791
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.6 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0791-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2023
2	NDC: 69968-0791-9	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2023
3	NDC: 69968-0791-3	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2023
4	NDC: 69968-0791-2	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2023
5	NDC: 69968-0791-4	3700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2023
6	NDC: 69968-0791-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2023
7	NDC: 69968-0791-6	2 in 1 PACKAGE	03/21/2023
7		1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	03/21/2023

Labeler - Kenvue Brands LLC (118772437)