LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT- 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 Ultraclean Antiseptic Cool Mint

Drug Facts

Active ingredientsPurposes
Eucalyptol (0.092%)Antiplaque/antigingivitis
Menthol (0.042%)Antiplaque/antigingivitis
Methyl Salicylate (0.060%)Antiplaque/antigingivitis
Thymol (0.064%)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

• 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% 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 ®

ULTRA CLEAN ®

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

4 IN 1

BENEFITS

  1. HELPS REDUCE & PREVENT HARD TO REMOVE BUILDUP (tartar)
  2. LONGER LASTING CLEAN †
  3. FIGHTS PLAQUE & GINGIVITIS
  4. KILLS 99% OF GERMS*

​

†vs. brushing alone *bad breath germs

COOL MINT ®

1.5 L (1 Qt 1Pt 2.7 Fl Oz)

Listerine_01

LISTERINE ULTRACLEAN ANTISEPTIC  COOL MINT
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0788
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:69968-0788-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2023
2NDC:69968-0788-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2023
3NDC:69968-0788-21500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2023
4NDC:69968-0788-92 in 1 PACKAGE02/05/2023
41500 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 finalpart35602/05/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 8/2023
Document Id: 031f1954-f96a-63dd-e063-6394a90a50fb
Set id: ee467ec4-bd5e-644a-e053-2a95a90ac273
Version: 3
Effective Time: 20230817
 
Johnson & Johnson Consumer Inc.