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

  • NDC Code(s): 69968-0477-1, 69968-0477-2, 69968-0477-3, 69968-0477-4, view more
    69968-0477-5, 69968-0477-6, 69968-0477-7
  • 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 November 21, 2019

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 water may cloud this product. Its antiseptic properties are not affected.
  • Inactive ingredients

    Water, Alcohol (21.6%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, Green 3

  • Questions or comments?

    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 - 3.7 LITER Bottle Label

    ANTISEPTIC
    LISTERINE®
    COOL MINT®

    KILLS 99.9% OF GERMS THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS
    FOR A FRESHER & CLEANER MOUTH THAN BRUSHING ALONE
    ADA
    Accepted

    American
    Dental
    Association®

    • Helps prevent and
      reduce plaque
    • Helps prevent and
      reduce gingivitis

    3.7 LITERS (1 Gallon)
    PROFESSIONAL SIZE FOR USE
    BY DENTISTS AND DENTAL HYGIENISTS

    PRINCIPAL DISPLAY PANEL - 3.7 LITER Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE COOL MINT ANTISEPTIC 
    eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0477
    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 Salicylate0.60 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:69968-0477-795 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2009
    2NDC:69968-0477-6250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2009
    3NDC:69968-0477-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2009
    4NDC:69968-0477-41000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2009
    5NDC:69968-0477-31500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2009
    6NDC:69968-0477-13700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2009
    7NDC:69968-0477-22 in 1 PACKAGE06/01/2009
    7NDC:69968-0477-31500 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 finalpart35606/01/2009
    Labeler - Johnson & Johnson Consumer Inc. (002347102)