Label: ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol rinse

  • NDC Code(s): 55316-318-69, 55316-318-86
  • Packager: DZA Brands, LLC
  • Category: HUMAN OTC DRUG LABEL

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 7, 2023

If you are a healthcare professional or from the pharmaceutical industry 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 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 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 not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine

  • Adverse reactions 

    Distributed by: DZA Brands, LLC

    2110 Executive Drive

    Salisbury, NC 28147

    For product questions or concerns contact us at 1-866-322-2439.  Please include UPC number and code from the package

  • Principal display panel

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    healthy

    accents

    original flavor

    antiseptic

    mouth rinse

    kills germs that cause bad breath, plaque & the gum disease gingivitis

    compare to the active

    ingredients of Listerine

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC  
    eucalyptol, menthol, methyl salicylate, thymol rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-318
    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:55316-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2008
    2NDC:55316-318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/05/2008
    Labeler - DZA Brands, LLC (090322194)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55316-318)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55316-318)