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

  • NDC Code(s): 37012-072-12, 37012-072-13, 37012-072-86
  • Packager: Shopko
  • 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 January 31, 2023

If you are a consumer or patient 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.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

  • Inactive ingredients

    water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D+C yellow no. 10, FD+C green no.3

  • Disclaimer

    This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Fresh Burst Listerine

  • Adverse Reactions Section

    Distributed by Shopko Stores Operating CO., LLC

    Green Bay, WI, 54307

    2012  ShopKo Stores Operating CO. LLC

    www.shopko.com

  • principal display panel

    SHOPKO

    COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE

    Antiseptic

    Mouth

    Rinse

    Spring Mint

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

    1.5 Liters (50.7 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:37012-072
    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 (UNII: 506T60A25R)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Spring Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/08/2008
    2NDC:37012-072-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/08/2008
    3NDC:37012-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/08/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/08/2008
    Labeler - Shopko (023252638)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(37012-072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(37012-072)