LISTERINE COOL MINT ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Listerine Cool Mint Antiseptic Mouthwash

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

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)

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label

ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

LISTERINE ®

COOL MINT ®

ANTISEPTIC

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.5 L (1 Qt 1Pt 2.7 Fl Oz)

Listerine_01

LISTERINE COOL MINT ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0791
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.6 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0791-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2023
2NDC:69968-0791-995 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2023
3NDC:69968-0791-3250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2023
4NDC:69968-0791-21500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2023
5NDC:69968-0791-43700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2023
6NDC:69968-0791-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2023
7NDC:69968-0791-62 in 1 PACKAGE03/21/2023
71500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/21/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 8/2023
Document Id: 031f6392-1d9e-8e4f-e063-6294a90a7863
Set id: edb9e374-4dba-5823-e053-2a95a90a3da5
Version: 3
Effective Time: 20230817
 
Johnson & Johnson Consumer Inc.