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

  • NDC Code(s): 55319-318-13, 55319-318-69, 55319-318-86
  • Packager: Family Dollar Services, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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

  • Active ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl Salicylate 0.060%

    Tymol 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 dentst 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 under 12 years of age - consult a dentist or doctor

    • this rinse is not intended to replace brushig 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 not manufactured or distributed by Johnson & Johnson Corporation, distributer of Original Listerine Antiseptic Mouthwash.

  • Adverse reactions

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

    MADE IN THE US WITH US AND FOREIGN COMPONENTS.

    Not 100% satisfied? Return within 30 days to the store of purchase for a refund (with receipt) or exchange.

    DSP-TN-21091

    DSP-MO-20087

  • Principal display panel

    Sealed with printed neckband for you protection.

    Do not use if band around cap is broken or missing.

    FAMILY Wellness

    COMPARE TO LISTERINE® ANTISEPTIC MOUTHWASH*

    ORIGINAL  ANTISEPTIC MOUTHRINSE

    Antigingivitis/Antiplaque Mouthrinse

    • Kills germs that cause bas breath, plaque and gingivitis gum disease

    1L (1.05 QT) 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:55319-318
    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 SALICYLATE0.60 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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/1991
    2NDC:55319-318-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/1991
    3NDC:55319-318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/1991
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/22/1991
    Labeler - Family Dollar Services, Inc (024472631)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55319-318)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55319-318)