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

  • NDC Code(s): 63940-318-86
  • Packager: Liberty Procurement, 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 7, 2023

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  • 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 manufactered or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Original Mouthwash

  • Adverse reactions

    Distributed by:

    Liberty Procurement, Inc.

    650 Liberty Ave.

    Union, NJ 07083 USA

    Visit us at: www.facevalues.com

    Satisfaction Guaranteed Or Your Money Back

  • Principal display panel

    Core Values

    Compare to Listerine Original*

    Original

    MOUTHWASH

    ANTISEPTIC

    Antigingivitis/Antiplaque

    Mouth Rinse

    Kills Germs that Cause

    Bad Breath, Plaque &

    the Gum Disease Gingivitis

    ADA Accepted

    American Dental Association

    • Hepls reduce plaque
    • Helps reduce gingivitis

    1 LITER (1 QT 1.8 FL OZ)

    Sealed With Printed Neckband For Your Protection

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-318
    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:63940-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/20/2016
    Labeler - Liberty Procurement, Inc (804085293)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63940-318)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(63940-318)
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