Label: LISTERINE NATURALS ANTISEPTIC - HERBAL MINT- eucalyptol, menthol, methyl salicylate, and thymol mouthwash

  • NDC Code(s): 42002-446-71, 42002-446-72
  • 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 September 9, 2020

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

  • 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

    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, sorbitol solution, alcohol (21.6%), poloxamer 407, flavor, benzoic acid, stevia rebaudiana leaf/stem extract, sodium benzoate

  • Questions?

    call toll-free 888-222-0182 or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

    LISTERINE®

    naturals™

    ANTISEPTIC

    Natural Antiseptics Kill 99%
    of the Germs that Cause
    Bad Breath, Plaque & the
    Gum Disease Gingivitis

    *vs. Original LISTERINE® Antiseptic      HERBAL MINT

    1.0L (1 Qt 1.8 Fl Oz)

    Principal Display Panel - 1.0 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE NATURALS ANTISEPTIC - HERBAL MINT 
    eucalyptol, menthol, methyl salicylate, and thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-446
    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:42002-446-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/201308/29/2021
    2NDC:42002-446-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/201308/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35612/15/201308/29/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)