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

  • NDC Code(s): 0363-0664-13, 0363-0664-69, 0363-0664-77, 0363-0664-86
  • Packager: Walgreens Co
  • 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 May 24, 2022

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  • 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

  • Warning

    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,  poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

  • Disclaimer

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

  • Questions

    Questions or comments? 1-800-925-4733

  • Adverse Reactions

    Our pharmacists recommend the Walgreens brand.  We invite you to compare to national brands.

    This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Listerine.

    DISTRIBUYTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED.

    walgreens.com  2021 Walgreen Co.

    MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS.

  • principal display panel

    wALGREENS

    WALGREENS-PHARMACIST RECOMMENDED

    Compare to the active ingredients in Listerine Cool Mint

    Mouth Rinse

    ANTIGINGIVITIS/ANTIPLAQUE

    Antiseptic

    • Kills germs that cause bad breath, plaque & the gum disease gingivitis

    ADA Accepted

    American Dental Association

    • Helps reduce plaque
    • Helps reduce gingivitis

    Refreshing Mint flavor

    33.8 FL OZ (1L)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0664
    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:0363-0664-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/24/1993
    2NDC:0363-0664-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/24/1993
    3NDC:0363-0664-69250 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package03/24/1993
    4NDC:0363-0664-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/24/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/24/1993
    Labeler - Walgreens Co (008965063)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0363-0664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0363-0664)
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