Label: ANTISEPTIC MOUTH RINSE- eucalyptol mouthwash

  • 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 19, 2011

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  • ACTIVE INGREDIENT

    Active ingredients
    Eucalyptol 0.092%, Menthol 0.042%
    Methyl salicylate 0.060%, Thymol 0.064%
  • PURPOSE

    Purpose
    Antiginvitis, Antiplaque
  • INDICATIONS & USAGE

    Use helps control plaque that leads to gingivitis
  • WARNINGS

    Warnings

    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
  • DOSAGE & ADMINISTRATION

    Directions • this rinse is not intended to replace brushing or flossing

    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

  • STORAGE AND HANDLING

    Other information cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰-77⁰F)
  • INACTIVE INGREDIENT

    Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel
  • SPL UNCLASSIFIED SECTION

    DSP-TN-15000
    DSP-MO-34
    SDS-TN-15012
  • ADVERSE REACTIONS

    Distributed by:
    Vi-Jon
    St. Louis, Missouri 63114
    Questions 1-888-593-0593
  • PRINCIPAL DISPLAY PANEL

    Child-Resistant Cap
    SEALED WITH PRINTED NECKBAND
    FOR YOUR PROTECTION
    Amber
    Antiseptic
    Mouth Rinse
    Kills germs that cause Plaque,
    Gingivitis and Bad Breath
    1.5 L (50.7 FL OZ)
    image of principal display panel


  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL.092 kg  in 100 L
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.042 kg  in 100 L
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE.060 kg  in 100 L
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL.064 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-318-861 L in 1 BOTTLE, PLASTIC
    2NDC:11344-318-69.25 L in 1 BOTTLE, PLASTIC
    3NDC:11344-318-121.5 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/04/2001
    Labeler - Vi-Jon (150931459)
    Registrant - Vi-Jon (150931459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon150931459manufacture
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