Label: ADVANCED ANTISEPTIC- eucalyptol mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 9, 2010

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients
    Eucalyptol 0.092%    Menthol 0.042%    Methyl salicylate 0.060%  Thymol 0.064%

    Purpose
    Antigingivitis, Antiplaque
  • INDICATIONS & USAGE

    Use helps control plaque that leads to gingivitis

  • WARNINGS

    Warnings

    Do not use if you have painful or swollen guns, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  This may be signs of periodontitis a serious form of gum disease.

    Stop use and as 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.

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 year of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then pit out; do not                                                                    swallow
    children under 12 year of age - consult a dentist or doctor
    • this rinse is not intended to replace brushing or flossing
  • STORAGE AND HANDLING

    Other information cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)
  • INACTIVE INGREDIENT

    Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40
  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine
  • ADVERSE REACTIONS

    DISTRIBUTED BY
    DEMOULAS SUPER MARKETS, INC
    875 EAST STREET
    TEWKSBURY, MASS.  01879
    MADE IN THE USA
  • SPL UNCLASSIFIED SECTION

    DSP-TN-15000

    DSP-MO-34

    SDS-TN-15012

  • PRINCIPAL DISPLAY PANEL

    Sealed With Printed Neckband For Your Protection
    Market Basket
    Compare to Citrus Advanced Listerine with Tartar Protection
    ADVANCED
    ANTISEPTIC
    MOUTH RINSE
    Citrus
    with Tartar Protection
    • Kills germs that cause bad breath, plaque + the gum disease gingivitis
    • Fights tartar buildup better than bushing alone
    • Keeps teeth cleaner + brighter
    1L (33.8 FL OZ)
    image of principal display panel

  • INGREDIENTS AND APPEARANCE
    ADVANCED ANTISEPTIC 
    eucalyptol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL.092 kg  in 100 L
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.042 kg  in 100 L
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE.060 kg  in 100 L
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL.064 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-210-861 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34807/22/2010
    Labeler - Demoulas Super Markets, Inc (007869647)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!