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

  • NDC Code(s): 69968-0239-1, 69968-0239-2, 69968-0239-3, 69968-0239-5
  • 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 April 23, 2020

If you are a consumer or patient please visit this version.

  • 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

    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% 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 - 1.5 L Bottle Label

    ANTISEPTIC
    LISTERINE®
    FRESHBURST®

    FOR A FRESHER &
    CLEANER MOUTH THAN
    BRUSHING ALONE

    ADA
    Accepted

    American
    Dental
    Association    ®

    1.5 L (1 Qt 1 Pt 2.7 fl oz)

    PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE FRESHBURST ANTISEPTIC 
    eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0239
    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:69968-0239-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2018
    2NDC:69968-0239-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2019
    3NDC:69968-0239-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/18/2018
    4NDC:69968-0239-31500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35608/17/2018
    Labeler - Johnson & Johnson Consumer Inc. (002347102)