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

  • NDC Code(s): 37012-318-12, 37012-318-86
  • Packager: Shopko Operating Co., LLC
  • 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 20, 2018

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

  • TEP

    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 imediately. 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 & Johnmson Healthcare Products, distributor of Original Listerine

  • Adverse Reaction

    Manufactured by Vi-Jon, Inc.,

    One Swan Dr., Smyrna TN 37167

    2012 ShopKo Stores Operating Co., LLC

    www. shopko.com

    For consumer questions

    call 1-888-593 0593

    318.003/318AH

  • Principal Display Panel

    Shopko

    COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE

    Antiseptic

    Mouth

    Rinse

    Original

    Kills Germs That Cause Bad Breath, Plaque & The Gum Disease Gingivitis

    1.5 Liters (50.7 FL OZ)

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  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-318
    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:37012-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/09/1991
    2NDC:37012-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/09/1991
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/09/1991
    Labeler - Shopko Operating Co., LLC (023252638)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(37012-318)