Label: ANTISEPTIC- eucayptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 50804-318-12, 50804-318-13, 50804-318-69, 50804-318-86
  • Packager: Perrigo Direct, Inc.
  • 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 June 7, 2023

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

  • Active ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl saliclate 0.060%

    Thymol 0.064%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    for this product

  • 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 dentist immediately. These may be signs of periodontitis, a serous 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.

  • 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

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

  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

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

    Distributed by

    Perrigo Direct, Inc.

    Peachtree City, GA 30269

    1-888-593-0593

    GoodSense is a registered trademark of L. Perrigo Company.

    DSP-TN21091

    DSP-MO-20087

  • Principal display panel

    Sealed With Printed Neckband For Your Protection

    GoodSense

    NDC 5084-318-12

    Antiseptic Mouth Rinse

    Original

    Kills Germs That Cause

    Bad Breath, Plaque & The Gum Disease Gingivitis

    ADA Accepted American Dental Association

    • Helps prevent and reduce plaque
    • Helps prevent and reduce gingivitis

    Compare to active ingredients of Listerine

    1.5 Liters (50.7 FLOZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    eucayptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-318
    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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1990
    2NDC:50804-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1990
    3NDC:50804-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1990
    4NDC:50804-318-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/15/1990
    Labeler - Perrigo Direct, Inc. (076059836)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(50804-318)