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 November 10, 2010

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

  • 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 you 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.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)
  • INACTIVE INGREDIENT

    Inactive ingredients water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow, FD+C green no. 3
  • SPL UNCLASSIFIED SECTION

    The ADA Council on Scientific  Affairs Acceptance of Good Sense Spring Mint Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

    This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine

    DISTRIBUTED BY:
    Vi-Jon
    8515 Page Avenue
    St. Louis, MO 63114
    1-888-593-0593

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

    Sealed With Printed
    Neckband For your Protection

    Compare to the Active Ingredients in Listerine

    Good Sense 
    NDC 11344-072-86

    ANTISEPTIC
    MOUTH RINSE

    Kills Germs that Cause
    Bad Breath, Plaque +
    The Gum Disease Gingivitis

    ADA
    Accepted
    American
    Dental
    Association

    1L (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:11344-072
    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
    ALCOHOL (UNII: 3K9958V90M)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-072-861 L in 1 BOTTLE, PLASTIC
    2NDC:11344-072-69.25 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/15/2009
    Labeler - Vi Jon (150931459)
    Registrant - Vi Jon (150931459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon150931459manufacture