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

  • NDC Code(s): 0869-0664-12, 0869-0664-13, 0869-0664-19, 0869-0664-69, view more
    0869-0664-77, 0869-0664-86, 0869-0664-88
  • 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 May 24, 2022

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

  • TEP

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Active Ingredients

    Eucalyptol 0.0692%

    Menthol 0.042%

    Methyl salicylate 0.060%

    Thymol 0.064%

  • Purpose

    Antigingivitis, antiplaque

  • Use

    help 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

    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
  • Inactive ingredients

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

  • ADA Council Statement

    The ADA Council on scientific affairs Acceptanc of Swan Blue Mint Antiseptic mouth rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plque above the gumline, when used as directed

  • Disclaimer

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

  • Adverse Reactions

    Distributed by: Vi-Jon, LLC

    One Swan Drive, Smyrna, TN 37167

  • principal display panel

    Meets current TSA's guidelines for carry-on luggage

    Swan

    ANTISEPTIC

    MOUTH RINSE

    ice mint

    Kills Germs that

    Cause Bad Breath

    Plaque & the Gum 

    Disease Gingivitis

    Compare to active ingredients

    of Listerine

    Sealed with printed neckband for your protection

    3.2 FL OZ (94 mL)

    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

    antiseptic

    mouth rinse

    antigingivitis/antiplaque

    blue mint

    1.5 L (50.7 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0664
    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:0869-0664-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1992
    2NDC:0869-0664-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1992
    3NDC:0869-0664-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1992
    4NDC:0869-0664-882000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1992
    5NDC:0869-0664-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1992
    6NDC:0869-0664-121250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1992
    7NDC:0869-0664-1994 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/15/1992
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0664)