Label: ANTISEPTIC- eucayptol, 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 September 4, 2012

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  • Active ingredients

    Active ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl saliclate 0.060%

    Thymol 0.064%

  • Purpose

    Purpose

    Antigingivitis, antiplaque

  • Use

    Use helps control plaque that leads to gingivitis

  • Warnings

    Warnings

  • Do not use

    Do not use if you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. See your dintist immediately. These may be sings of periodontitis, a serous form of gum disease.

  • Stop use

    Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks

  • Keep out of reach of children.

    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.

  • Directions

    Directions

    adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsfuls) 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
  • Other information

    Other information cold weather may cloud this product. Its antiseptic properites are not affected. Store at room temperature (59°-77°F).

  • Inactive ingredients

    Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

  • ADA Information

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

  • Disclaimer

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

    25% more than the 1 L size

  • Adverse reaction section

    Distributed by:

    Geiss, Destin + Dunn, Inc

    Peachtree City, GA 30269

    www.valuelabels.com

    1-866-696-0957

    DSP-TN-15000

    DSP-MO-34

    SDA-TN 15012

  • Principal display panel

    25% MORE FREE

    GoodSense

    Antiseptic

    Mouth Rinse

    Original

    ADA

    Accepted

    American Dental Association

    Kills Germs That Cause

    Bad Breath, Plaque + The Gum Disease Gingivitis

    Compare to active ingredient of Listerine

    Sealed With Printed Neckband For Your Protection

    1.25 Liter (42.3 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    eucayptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-318
    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) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.060 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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-318-69.25 L in 1 BOTTLE, PLASTIC
    2NDC:75981-318-121.5 L in 1 BOTTLE, PLASTIC
    3NDC:75981-318-861 L in 1 BOTTLE, PLASTIC
    4NDC:75981-318-131.25 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/15/1990
    Labeler - Geiss, Destin + Dunmn, Inc (076059836)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(75981-318)
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