LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT- eucalyptol, menthol, unspecified form, methyl salicylate, and 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 Ultraclean Antiseptic

Cool Mint

Drug Facts

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Purposes

Antiplaque/antigingivitis

Uses

helps prevent and reduce:

Warnings

Do not use in children under 12 years of age

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

Other information

Inactive ingredients

Water, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Zinc Chloride, Flavor, Sodium Benzoate, Sucralose, Sodium Saccharin, 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

ANTISEPTIC

LISTERINE®

ULTRACLEAN

FOR UP TO A 3X

LONGER LASTING

CLEAN FEELING*

*VS. brushing alone

1.5 L (1 Qt 1 Pt 2.7 Fl Oz)

COOL MINT®

Listerine

LISTERINE ULTRACLEAN ANTISEPTIC  COOL MINT
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0539
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.42 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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0539-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201209/17/2023
2NDC:69968-0539-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2012
3NDC:69968-0539-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2012
4NDC:69968-0539-31500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2012
5NDC:69968-0539-42 in 1 PACKAGE06/01/2012
5NDC:69968-0539-31500 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 finalpart35606/01/2012
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 3/2023
Document Id: f789c892-8cfb-f80a-e053-6394a90ad09a
Set id: dd3729c2-fd05-4db0-a542-487bb0f9001f
Version: 8
Effective Time: 20230322
 
Johnson & Johnson Consumer Inc.