Label: EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL mouthwash

  • NDC Code(s): 53942-855-12
  • Packager: Demoulas Super Markets, 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 June 5, 2023

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

  • Active ingredient

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl salicylate 0.060%

    Thymol 0.064%

  • Purpose

    Antigingivitis, antiplaque

  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    for this product

  • Do not use

    if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

  • Stop use and ask a dentist if

    gingivitis, bleeding, or redness persists for more than 2 weeks

  • 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

    adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

    children 6 years to under 12 years of age - supervise use

    children under 6 years of age - do not use

    • this rinse is not intended to replace brushing or flossing
  • Other information

    cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-86°F)

  • Inactive ingredients

     water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Johnson & Johnson Healthcare products, distributor of Listerine Ultraclean With Everfresh Technology - Cool Mint.

    DISTRIBUTED BY

    DEMOULAS SUPER MARKETS, INC.

    875 East Street

    TEWKSBURY, MA 01876

  • Principal display panel

    "MORE FOR YOUR DOLLAR"

    MARKET BASKET

    Compare to Listerine Ultraclean Cool Mint*

    TARTAR CONTROL PLUS

    ANTISEPTIC

    ANTIGINGIVITIS/ANTIPLAQUE

    MOUTH RINSE

    Blue Mint

    Fights tartar build-up

    better than

    brushing alone

    Sealed With Printed Neckband For Your Protection

    1.5 L (50.7 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-855
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 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)  
    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:53942-855-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/05/2023
    Labeler - Demoulas Super Markets, Inc (007869647)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(53942-855)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(53942-855)