Label: ANTISEPTIC MOUTH RINSE- 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 September 13, 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

    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 years 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
    AMERICAN SALES COMPANY
    4201 WALDEN AVENUE
    LANCASTER, NY14086

    QUALITY GUARANTEED OR YOUR MONEY BACK

  • SPL UNCLASSIFIED SECTION

    DSP-TN-15000
    DSP-MO-34
    SDS-TN-15012
  • PRINCIPAL DISPLAY PANEL

    Compare to Citrus Advanced Listerine with Tartar Protection
    Sealed with Printed Neckband for Your protection  
    Care One
    Antiseptic
    MOUTH
    RINSE
    Tartar protection + Control
    Citrus flavor
    •Helps fight tartar buildup
    •Fights plaque and gingivitis
    • Kills germs for extended plaque protection
    • Enhanced breath protection
    1 Liter
    (33.8 FL OZ)
    image of principal display panel

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-210
    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:41520-210-131.25 L in 1 BOTTLE, PLASTIC
    2NDC:41520-210-861 L in 1 BOTTLE, PLASTIC
    3NDC:41520-210-121.5 L in 1 BOTTLE, PLASTIC
    4NDC:41520-210-69.25 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/02/2010
    Labeler - American Sales Company (809183973)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture
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