Label: ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol 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 April 2, 2012

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  • ACTIVE INGREDIENT

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl sailcylate 0.060%

    THYMOL 0.064%

    Purpose
    Antigingivitis
  • 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  • this rinse is not intended to replace brushing or flossing
    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 the spit out; do not swallow
    children under 12 years of age - consult a dentist or doctor
  • 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
    DSP-TN-15000
    DSP-MO-34
    SDS-TN-15012
  • ADVERSE REACTIONS

    Distributed By:
    Geiss, Destin +Dunn, Inc
    385 Highway 74 South
    Peachtree, GA 30269
    www.valuelabels.com
  • PRINCIPAL DISPLAY PANEL

    Sealed With Printed Neckband For Your Protection
    GoodSense
    Antiseptic
    Citrus
    Tartar Protection
    •Helps fight tartar buildup
    •Fights plaque and gingivitis
    •Kill germs for extended plaque protection
    •Enhanced breath protection
    Compare to Citrus Advanced Listerine
    with Tartar Protection
    250 mL (8.5 FL OZ)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.092 kg  in 100 L
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.042 kg  in 100 L
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE0.060 kg  in 100 L
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.064 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-210-690.25 L in 1 BOTTLE, PLASTIC
    2NDC:75981-210-861.5 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/09/1993
    Labeler - Geiss, Destin + Dunn (076059836)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture
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