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

  • NDC Code(s): 41250-072-12, 41250-072-69, 41250-072-77, 41250-072-86
  • Packager: Meijer Distribution, 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 January 30, 2023

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  • TEP

    Sealed With Printed Neckband For Your Protection

  • active ingredent

    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 serios 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 ingredient

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

  • Questions

    Call 1-888-593-0593

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, Distributor of FreshBurst Listerne Antiseptic Mouthwash.

    DISTRIBUTED BY

    MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    Meijer Pharmacist Recommended

    Money Back Guarantee

  • principal display panel

    NDC 41250-072-86

    Compare to FreshBurst Listerine Antiseptic Mouthwash*

    meijer

    mouth rinse

    Antigingivitis/Antiplaque

    Antiseptic

    Fresh Mint

    Kills germs that cause bad breath, plaque and gingivitis

    ADA Accepted

    American Dental Association

    • Helps reduce plaque
    • Helps reduce gingivitis

    33.8 FL OZ (1L)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-072
    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 SOLUTION (UNII: 8KW3E207O2)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-072-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/1996
    2NDC:41250-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/1996
    3NDC:41250-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/1996
    4NDC:41250-072-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/1996
    Labeler - Meijer Distribution, Inc (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41250-072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41250-072)
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