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

  • NDC Code(s): 68016-941-77
  • Packager: Pharmacy Value Alliance LLC
  • Category: HUMAN OTC DRUG LABEL

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 healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl salicylate 0.060%

    Thymol 0.064%

  • Purpose section

    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 solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no.10, FD&C green no.3

  • Questions?

    1-888-593-0593

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Freshburst Listerine Antiseptic Mouthwash.

    If for any reason you are not satisified with this product, please return it to the store where purchased for a full refund.

    Distributed by:

    Pharmacy Value Alliance LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

  • principal display panel

    SEALED WITH PRINTED NECKBAND FOR Y0UR PROTECTION

    COmPARE TO FRESHBURST LISTERINE ANTISEPTIC MOUTHWASH*

    Premier Value

    Antiseptic Mouthrinse

    Antigingivitis/Antiplaque

    spring mint

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

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANITSEPTIC MOUTH RINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-941
    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:68016-941-771000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/19/2003
    Labeler - Pharmacy Value Alliance LLC (101668460)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(68016-941)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(68016-941)