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

  • NDC Code(s): 0869-0318-12, 0869-0318-13, 0869-0318-19, 0869-0318-69, view more
    0869-0318-77, 0869-0318-86
  • Packager: Vi-Jon, LLC
  • 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 April 19, 2022

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

  • Active ingredients

    Eucalyptol 0.092%, Menthol 0.042%
    Methyl salicylate 0.060%, Thymol 0.064%

  • Purpose

    Antiginvitis, 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 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 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

    The ADA Council on Scientific Affairs' Acceptance of Swan Original Antiseptic Mouthrinse 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.

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

    DSP-TN-15000
    DSP-MO-34
    SDS-TN-15012

  • Adverse reaction section

    Distributed by: Vi-Jon, LLC One Swan Drive, Smyrna, TN 37167

    Questions or Comments? 1-888-593-0593

    Made in the USA

    with US and foreign parts

  • principal display panel

    Sealed With Printed Neckband For Your Protection

    ANTISEPTIC

    Mouth Rinse

    original

    Kills Germs that

    Cause Bad Breath

    Plaque & the Gum

    Disease Gingivitis

    Compare to the active ingredients of Listerine

    1.5 LITERS (50.7 FL OZ)

    ADA

    Accepted

    American

    Dental

    Association

    Compare to the active ingredients of Listerine

    1.5 Liters (50.7 FL OZ)

    image description

  • principal display panel

    mountain

    falls

    *Compare

    to Listerine

    improves

    oral

    hygiene

    kills germs

    that cause bad

    breath, plaque

    and gingivitis

    gum disease

    for

    daily

    mouth

    care

    freshens breath

    antiseptic

    mouth rinse

    antigingivitis/antiplaque

    original

    1.5 L (50.7 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0318
    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:0869-0318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    2NDC:0869-0318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    3NDC:0869-0318-121500 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package07/15/1989
    4NDC:0869-0318-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    5NDC:0869-0318-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    6NDC:0869-0318-1994 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/15/1989
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0318)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0318)