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

  • 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 April 10, 2023

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  • Ohter Safety Information

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    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 (59⁰ - 77⁰F)

  • Inactive ingredients

    water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of FreshBurst® Listerine® Antiseptic Mouthwash.

    Distributed by:

    Marc Glassman, Inc

    West 130th Street

    Cleveland, OH 44130

    DSP-TN-15000

    DSP-MO-34

  • principal display panel

    Marc's

    *Compare to FreshBurst® Listerine® Mouthwash

    Antiseptic Mouthwash

    Antigingivitis/Antiplaque

    HELPS REDUCE PLAQUE AND REFRESH BREATH

    Kills Germs that Cause

    • Bad Breath
    • Plaque
    • Gingivitis Gum Disease

    Spring Mint Flavor

    1.5L (1.58 QT) 50.7 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol, menthol, methyol salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-072
    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 SOLUTION (UNII: 8KW3E207O2)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/22/2019
    Labeler - Marc Glassman, Inc (094487477)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(68998-072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(68998-072)
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