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

  • NDC Code(s): 0869-0072-12, 0869-0072-13, 0869-0072-19, 0869-0072-21, view more
    0869-0072-50, 0869-0072-69, 0869-0072-77, 0869-0072-86, 0869-0072-88
  • 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 February 2, 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

    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 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 (59°-77°F).

  • inactive ingredents

    water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no. 3

  • ADA council statement

    “The ADA Council on Scientific Affairs’ Acceptance of Swan Spring Mint® Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.”

  • safety information

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • disclaimer

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

    DSP-TN-1500  DSP-MO-34 SDS-TN-15012

  • Adverse Reactions

    Distributed By: Vi-Jon, LLC

    8515 Page Ave.,  St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

  • principal display panel

    NDC 0869-0072-69

    Sealed With Printed Neckband For Your Protection

    SWAN

    ANTISEPTIC

    MOUTH RINSE

    spring mint

    Kills Germs that Cause

    Bad Breath, Plaque & the

    Gum Disease Gingivitis

    Compare to FreshBurst Listerin

    ADA

    Accepted

    American

    Dental

    Association

    250 mL (8.5 FL OZ)

    image description

  • principal display panel

    Mountain

    Falls

    Compare to Listerine

    improves oral hygiene

    for daily mouth care

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

    freshens breath

    antiseptic

    mouth rinse

    antigingivitis/antiplaque

    spring mint

    500 mL (16.9 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC  
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0072
    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 CITRATE (UNII: 1Q73Q2JULR)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0072-2189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    2NDC:0869-0072-882000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    3NDC:0869-0072-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    4NDC:0869-0072-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    5NDC:0869-0072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    6NDC:0869-0072-1994 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    7NDC:0869-0072-50710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    8NDC:0869-0072-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    9NDC:0869-0072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/20/1988
    Labeler - Vi Jon, LLC (790752542)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(0869-0072)