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

  • NDC Code(s): 67732-124-77, 67732-124-86
  • Packager: Duane Reade
  • 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 October 21, 2019

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

  • 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

  • Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen guns, pus fro the gum line, loose teeth or increased spacing between the teeth.  These may be signs of periodontitis, a serious form of gum disease.

    Keep out of reach of children under  6 years of age.  If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Keep out of reach of children

    Keep out of reach of children under 6 years of age. 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 teaspoonsful) between your teeth twice a day for 30 seconds then spit out.  Do not swallow the rinse.
    • children 6 years to under 12 years of age: supervise use
    • children under 6 years of age: do not use
  • Other information

    • this rinse is not intended to replace brushing or flossing
    • cold weather may cloud this product.  Its antiseptic properties are not affected.

    Store at room temperatures (59⁰-77⁰F)

  • Inactive ingredients

    water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sucralose and/or sodium saccharin, sodium benzoate, propylene glycol alginate, FD&C yellow no. 6, FD&C blue no. 1

  • TEP

    Sealed With Printed Neckband For Your Protection

  • principal display panel

    vanilla mint

    antiseptic mouthwash

    for fresher breath

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

    1 liter 33.8 fl oz

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC  
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-124
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-124-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/08/2006
    2NDC:67732-124-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/08/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/08/2006
    Labeler - Duane Reade (011988995)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture(67732-124)