Label: LISTERINE FRESHBURST ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 69968-0792-1, 69968-0792-2, 69968-0792-3, 69968-0792-5
  • 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 INGREDIENT

    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:

    • plaque
    • gingivitis
  • Warnings

    Do not use in children under 12 years of age


    ASK A DENTIST


    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, Sodium Saccharin, Flavor, Sodium Benzoate, Yellow 10, 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 - 1500 mL Bottle Label

    ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

    LISTERINE ®

    FRESHBURST ®

    ANTISEPTIC

    FOR A FRESHER &

    CLEANER MOUTH THAN

    BRUSHING ALONE

    ADA

    Accepted

    American

    Dental

    Association ®

    1.5 L (1 Qt 1 Pt 2.7 Fl Oz)

    Listerine_01

  • INGREDIENTS AND APPEARANCE
    LISTERINE FRESHBURST ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0792
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0792-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2023
    2NDC:69968-0792-3250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2023
    3NDC:69968-0792-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2023
    4NDC:69968-0792-21500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02204/21/2023
    Labeler - Kenvue Brands LLC (118772437)
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