Label: MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 55910-318-12, 55910-318-77, 55910-318-86
  • Packager: Old East Main Co
  • 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 6, 2023

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  • TEP

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Active ingredient

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl salicylate 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 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

  • Directions

    adults and children 12 years 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

  • Other information

     cold weather may cloud this product, its antiseptic properties are not affected.  Store at room temperature (59⁰-77⁰F)

  • Inactive ingredients

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

  • Disclaimer

    100% Satisfaction Guaranteed

    If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

    (888)309-9030

    Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

    Distributed by Old East Main Co.

    100 Mission Ridge

    Goodlettsville, TN 37072

    DSP-TN-21091

    DSP-MO-20087

  • principal display panel

    DG health

    Compare to Original Listerine Antiseptic Mouthwash*

    ANTISEPTIC

    MOUTHWASH

    Antigingivitis/Antiplaque

    AMBER

    KILLS 99.9% OF GERMS COMMONLY ASSOCIATED WITH GINGIVITIS

    Fights bad breath

    Helps reduce plaque 

    1.5L (50.7 FL OZ)

    image description

  • principal display panel

    Since 1903

    Rexall

    Amber

    Antiseptic

    Mouthwash

    Antigingivitis/Antiplaque

    • Kills 99.9% of germs commonly associated with gingivitis
    • Fights bad breath
    • Helps reduce plaque

    ADA Accepted

    Amrican Dental Association

    • Helps reduce plaque
    • Helps reduce gingivitis

    1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    MOUTH RINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-318
    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:55910-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2001
    2NDC:55910-318-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2001
    3NDC:55910-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/11/2001
    Labeler - Old East Main Co (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-318)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-318)
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