Label: ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 53942-318-12, 53942-318-13, 53942-318-86
  • Packager: Demoulas Super Markets
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 19, 2024

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

  • Active ingredients

    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 periodtitis, 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 chrildren

    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 under 12 years of age - consult a dentist or doctor

    • 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°-77°F).

  • Inactive ingredients

    water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

  • Disclaimer

    *This product is manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine.

  • Adverse reaction

    DISTRIBUTED BY

    DEMOULAS SUPER MARKETS, INC.

    875 EAST STREET

    TEWKSBURY, MA 01876

  • Principal display panel

    "MORE FOR YOUR DOLLAR"

    MARKET BASKET

    Compare to Listerine*

    ANTISEPTIC

    MOUTH RINSE

    Original

    Kills germs that

    cause Bad Breath,

    Plaque and the gum

    disease Gingivitis

    ADA Accepted

    American Dental Association

    • Helps reduce plaque
    • Helps reduce gingivitis

    Sealed With Printed Neckband For Your Protection

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-318
    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 SALICYLATE0.6 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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1990
    2NDC:53942-318-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1990
    3NDC:53942-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/15/1990
    Labeler - Demoulas Super Markets (007869647)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(53942-318)