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

  • NDC Code(s): 37012-664-12, 37012-664-13, 37012-664-19, 37012-664-86
  • Packager: Shopko Store 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 December 5, 2022

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  • TEP

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Claim

    SHOPKO

  • 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 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

  • Disclaimer

    This product is not manufactured or distribted by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine

  • Adverse Reactions

    Manufactured by Vi-Jon, LLC.,

    One Swan Dr., Smyrna, TN 37167

    2012 Shopko Stores Operating Co., LLC

    www.shopko

    For consumer questions

    call 1-888-593-0593

    SHOPKO

    Satisfaction

    Guaranteed

    BNy Refund Or Exchange

    DSP-TN-15000

    DSP-MO-34

    SDS-TN-15012

  • principal display panel

    SHOPKO

    COMPARE TO THE INGREDIENTS OF LISTERINE

    Antiseptic

    Mouth

    Rinse

    Blue Mint

    Kills Germs that Cause Bad Beath,

    Plaque & The Gum Disease Gingivitis

    1.5 Liters (50 .7 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-664
    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 BENZOATE (UNII: OJ245FE5EU)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-664-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2008
    2NDC:37012-664-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2008
    3NDC:37012-664-131200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2008
    4NDC:37012-664-1994 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/02/2008
    Labeler - Shopko Store Operating Co, LLC (023252638)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37012-664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37012-664)
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