Label: LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash

  • NDC Code(s): 69968-0539-1, 69968-0539-2, 69968-0539-3, 69968-0539-4, view more
    69968-0539-5
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 22, 2023

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  • SPL UNCLASSIFIED SECTION

    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

    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% 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)

  • SPL UNCLASSIFIED SECTION

    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

  • INGREDIENTS AND APPEARANCE
    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)
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