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

  • NDC Code(s): 69968-0605-5
  • 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 14, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Eucalyptol (0.092%) Antiplaque/antigingivitis
    Menthol (0.042%)Antiplaque/antigingivitis
    Methyl Salicylate (0.060%)Antiplaque/antigingivitis
    Thymol (0.064%)Antiplaque/antigingivitis
  • Use

    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 20mL (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, Sorbitol, Alcohol (21.6% v/v), Poloxamer 407, Flavor, Benzoic Acid, Stevia Rebaudiana Leaf Extract, Sodium Benzoate

  • 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 - 500 mL Bottle Label

    LISTERINE®
    NATURALS

    ANTISEPTIC

    HEALTHIER GUMS

    POWERED BY GERM-NEUTRALIZING
    ESSENTIAL OILS FOR HEALTHIER GUMS

    HERBAL MINT

    500 mL (1 .05 Pt)

    Principal Display Panel - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE NATURALS ANTISEPTIC 
    eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0605
    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)  
    Sorbitol (UNII: 506T60A25R)  
    Alcohol (UNII: 3K9958V90M)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0605-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/06/2020
    Labeler - Johnson & Johnson Consumer Inc. (002347102)