LISTERINE ULTRACLEAN ARCTIC 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 ARCTIC 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:

  • Plaque
  • gingivitis

Warnings

Do not use in children under 12 years of age

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

  • 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, Flavor, Benzoic Acid, Zinc Chloride, Sodium Benzoate, Sucralose, Sodium Saccharin, Blue 1

Questions ?

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

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ANTISEPTIC
LISTERINE ®
ULTRACLEAN

FOR UP TO A 3X
LONGER LASTING
CLEAN FEELING*

*vs. brushing alone

ARCTIC MINT ®

500 mL (1.05 Pt)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE ULTRACLEAN ARCTIC MINT 
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0399
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 BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0399-395 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201209/26/2023
2NDC:69968-0399-8250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201203/29/2023
3NDC:69968-0399-9500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201209/25/2023
4NDC:69968-0399-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201209/25/2023
5NDC:69968-0399-21500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/201208/17/2023
6NDC:69968-0399-42 in 1 PACKAGE07/03/201209/27/2023
6NDC:69968-0399-21500 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 finalpart35607/03/201209/27/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 3/2023
Document Id: f6c397ec-1537-5a36-e053-6394a90a055e
Set id: be6ea17b-2b72-4354-a2fa-e3aac0d5d7d9
Version: 7
Effective Time: 20230313
 
Johnson & Johnson Consumer Inc.