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

  • NDC Code(s): 59779-072-09, 59779-072-12, 59779-072-69, 59779-072-77, view more
    59779-072-86
  • Packager: CVS Pharmacy, 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 27, 2020

If you are a consumer or patient please visit this version.

  • Active ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl salicylate 0.030%

    Thymol 0.064%

  • purpose

    antigingivituis, 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

    • do not swallow
    • not inteneded to replace brushing or flossing

    adults and children 12 years of age and older - vigorously swish 20 ml between teeth for 30 seconds then spit out

    children under 12 years of age - consult a dentist or doctor

  • Other information

    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

  • disclaimer

    This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine FreshBurst Antiseptic

  • Adverse reactions

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    2016 CVS/pharmacy

    CVS.com  V-16224

    072.002/072AL

  • principal display panel

    CVS

    Healh

    Compare to the active ingredients in Listerine FreshBurst Antiseptic

    Antiseptic

    Mouthwash

    ANTIGINGIVITIS/ANTIPLAQUE

    Kills germs that cause plaque, gingivitis & bad breath

    Green Mint

    ADA

    Accepted

    American

    Dental

    Association

    Sealed with printed neckband for your protection. Do not use if broken or missing.

    1.5 L (50.7 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-072
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-072-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
    2NDC:59779-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
    3NDC:59779-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
    4NDC:59779-072-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
    5NDC:59779-072-09887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/09/1995
    Labeler - CVS Pharmacy, Inc (062312574)
    Registrant - Vi-Jon (790752542)