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

  • NDC Code(s): 62011-0467-1
  • Packager: Strategic Sourcing Services 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 January 30, 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 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 year 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 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D&C yellow no.10,

    FD&C green no.3

  • SPL UNCLASSIFIED SECTION

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

    McKESSON

    Another Quality Product Distributed by McKesson, One Post Street, San Francisco, CA 94104

    Money Back Guarantee   www.healthmart.com/healthmartbrand

  • principal display panel

    Health Mart

    Compare to FreshBurst Listerine Antiseptic Mouthwash*

    Antiseptic Mouthrinse

    antigingivitis/antiplaque

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

    2X DAY PROTECTION

    Spring Mint

    1 L (1 QT 1.8 FL OZ) 33.8 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:62011-0467
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0467-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/14/1995
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(62011-0467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(62011-0467)
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