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

  • NDC Code(s): 42002-402-63, 42002-402-70, 42002-402-71, 42002-402-72, view more
    42002-402-73, 42002-402-94, 42002-402-95
  • 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 25, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Eucalyptol 0.092% }
    Menthol 0.042% }
    Methyl salicylate 0.060% }
    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%),sorbitol solution, flavoring, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no. 3

  • Questions?

    call 1-888-222-0182, weekdays

  • SPL UNCLASSIFIED SECTION

    Dist: Johnson & Johnson Healthcare Products
    Division of McNEIL-PPC, Inc.
    Skillman, NJ 08558-9418 USA

  • PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

    LISTERINE®
    COOL MINT®
    ANTISEPTIC

    Kills Germs that Cause
    Bad Breath, Plaque & the
    Gum Disease Gingivitis

    ADA
    Accepted

    American
    Dental
    Association®

    1.0L (1 Qt. 1.8 Fl Oz)

    PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE COOL MINT ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, and thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-402
    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:42002-402-9595 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/27/2020
    2NDC:42002-402-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/27/2020
    3NDC:42002-402-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/08/2020
    4NDC:42002-402-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/29/2020
    5NDC:42002-402-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201212/27/2020
    6NDC:42002-402-633700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/201201/31/2021
    7NDC:42002-402-942 in 1 PACKAGE02/21/201202/01/2021
    7NDC:42002-402-701500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35602/21/201202/01/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)