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

  • NDC Code(s): 69968-0550-1, 69968-0550-2, 69968-0550-3, 69968-0550-4, view more
    69968-0550-5, 69968-0550-8, 69968-0550-9
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

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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

    Listerine

    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%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3

  • Questions or Comments?

    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     ®

    COOL MINT®

    FOR A FRESHER &

    CLEANER MOUTH THAN

    BRUSHING ALONE

    ADA

    Accepted

    American

    Dental

    Association ®

    1.5L (1 Qt 1 Pt 2.7 fl oz)

    Listerine_001

  • INGREDIENTS AND APPEARANCE
    LISTERINE COOL MINT ANTISEPTIC 
    eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0550
    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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0550-995 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/2018
    2NDC:69968-0550-2250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/2018
    3NDC:69968-0550-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/2018
    4NDC:69968-0550-1946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/2018
    5NDC:69968-0550-41419.529 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/2018
    6NDC:69968-0550-33700 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    7NDC:69968-0550-82 in 1 PACKAGE11/24/2020
    7NDC:69968-0550-41419.529 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/03/2018
    Labeler - Kenvue Brands LLC (118772437)
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