Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • Category: HUMAN OTC DRUG LABEL

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 February 25, 2013

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  • Active ingredients

    Active ingredients

    Eucalyptol 0.0692%

    Menthol 0.042%

    Methyl salicylate 0.060%

    Thymol 0.064%

  • Purpose

    Purpose

    Antigingivitis, antiplaque

  • Use

    Use help control plaque that leads to gingivitis

  • Warnings

    Warnings

  • Do not use

    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

    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 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

    children unmder 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 properties are not affected. Store at room temperature (59°-77°F)

  • Inactive ingredients

    Inactive ingredients water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD+C green no.3

  • Adverse Reactions

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

  • Disclaimer

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

  • Adverse Reactions

    Distributed By:

    Geiss, Destin + Dunn, Inc

    Peachtree City, GA 30269

    www.valuelabels.com

    1-866-696-0957

  • Principal Display Panel

    25% MORE FREE

    GoodSense

    NDC 75987-664-13

    Antiseptic

    Mouth Rinse

    Blue Mint

    ADA

    Accepted

    American

    Dental

    Associatin

    Kills Germs That Cause

    Bad Breath, Plaque + The Gum

    Disease Gingivitis

    Compare to active ingredients of

    Listerine

    Sealed With Printed Neckband For Your Protection

    1.25 LITER (42.3 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-664
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-664-131250 mL in 1 BOTTLE, PLASTIC
    2NDC:75981-664-121500 mL in 1 BOTTLE, PLASTIC
    3NDC:75981-664-69250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/01/1992
    Labeler - Geiss, Destin + Dunn, Inc. (076059836)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(75981-664)
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