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

  • NDC Code(s): 69968-0788-1, 69968-0788-2, 69968-0788-5, 69968-0788-9
  • 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 August 17, 2023

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  • 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

    Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use

    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

    • this rinse is not intended to replace brushing or flossing
    • 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, Zinc Chloride, Flavor, Sodium Benzoate, Sucralose, Sodium Saccharin, 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 ®

    ULTRA CLEAN ®

    ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

    4 IN 1

    BENEFITS

    1. HELPS REDUCE & PREVENT HARD TO REMOVE BUILDUP (tartar)
    2. LONGER LASTING CLEAN †
    3. FIGHTS PLAQUE & GINGIVITIS
    4. KILLS 99% OF GERMS*

    ​

    †vs. brushing alone *bad breath germs

    COOL MINT ®

    1.5 L (1 Qt 1Pt 2.7 Fl Oz)

    Listerine_01

  • INGREDIENTS AND APPEARANCE
    LISTERINE ULTRACLEAN ANTISEPTIC  COOL MINT
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0788
    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)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0788-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2023
    2NDC:69968-0788-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2023
    3NDC:69968-0788-21500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2023
    4NDC:69968-0788-92 in 1 PACKAGE02/05/2023
    41500 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 finalpart35602/05/2023
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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