Label: ADVANCED CITRUS- eucalyptol mouthwash

  • 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 August 27, 2010

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  • 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

    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.
  • DOSAGE & ADMINISTRATION

    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 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 (59⁰-77⁰F).
  • INACTIVE INGREDIENT

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

    Satisfaction guaranteed-Or we'll replace it or give you  your money back.  For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

    Distributed by Wal-Mart Stores, Inc.,
    Bentonville, AR 72716 Wal-Mart Stores,Inc
  • SPL UNCLASSIFIED SECTION

    This product is  not manufactured or distributed by Johnson +Johnson Healthcare Products, distributor of Listerine.
    DSP-TN-15000   DSP-MO-34   SDS-TN-15012
  • PRINCIPAL DISPLAY PANEL

    Compare to Citrus Listerine Active Ingredients

    Advanced
    Antiseptic Mouthrinse
    With Tartar Protection

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

    •Fights tartar buildup better than brushing alone

    •Keeps teeth cleaner and brighter

    Citrus

    1.5 LITERS (50.7 FL OZ)

    image of package label

  • INGREDIENTS AND APPEARANCE
    ADVANCED CITRUS 
    eucalyptol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-210
    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)  
    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:49035-210-69.25 L in 1 BOTTLE, PLASTIC
    2NDC:49035-210-77.5 L in 1 BOTTLE, PLASTIC
    3NDC:49035-210-121.5 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/22/2010
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture
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