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

  • NDC Code(s): 41163-318-12, 41163-318-13, 41163-318-77, 41163-318-86
  • Packager: United Natural Foods, Inc. dba UNFI
  • 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 May 10, 2023

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  • Active ingredients

    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 is 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

  • TEP

    Sealed With Printed Neckband For Your Protection

  • Disclaimer

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Original Listerine Antiseptic Mouthwash.

  • Adverse reactions

    Like it or let us make it right.

    That's our quality promise.

    8556-423-2630

    DISTRIBUTED BY UNFI

    PROVIDENCE, RI 02908 USA

    DSP-TN-21091

    DSP-MO-20087

  • Principal display panel

    NDC 41163-318-86

    Compare to Oringinal Listerine Antiseptic Mouthwash active ingredients*

    EQUALINE

    antiseptic

    mouthrinse

    antigingivitis/antiplaque

    • kills germs that cause bad breath, plaque and gingivitis gum disease

    amber

    1.L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    MOUTH RINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-318
    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:41163-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2005
    2NDC:41163-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2005
    3NDC:41163-318-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2005
    4NDC:41163-318-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/04/2005
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41163-318)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41163-318)
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