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

  • NDC Code(s): 55316-664-69, 55316-664-77, 55316-664-86
  • Packager: DZA Brands 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 March 16, 2016

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

  • Active ingredients

    Active ingredients

    Eucalyptol 0.0692%

    Menthol 0.042%

    Methyl salicylate 0.060%

    Thymol 0.064%

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  • Purpose

    Antigingivitis, antiplaque

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  • Use

    help control plaque that leads to gingivitis

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  • Warnings

    for this product

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  • 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.

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  • Stop use and ask a dentist if

    gingivitis, bleeding, or redness persists for more than 2 weeks.

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  • 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.

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  • Directions

    • do not swallow
    • not intended to replace brushing or flossing

    adults and children 12 years of age and older - vigorously swish 20 mL between teeth for 30 seconds then spit out

    children under 12 years of age - consult a dentist or doctor

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  • Other information

    Store at room temperature (59°-77°F)

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  • Inactive ingredients

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

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  • Disclaimer

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

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  • Adverse Reactions

    Distributed by: DZA Brands, LLC

    2110 Executive Drive

    Salisbury, NC 28147

    For product questions or concerns contact us at 1-866-322-2439. Please include UPC number and code from package

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  • Package Label

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    healthy

    accents

    blue mint

    antiseptic

    mouth rinse

    kills germs that cause bad breath,

    plaque & the gum disease gingivitis

    compare to the active

    ingredient of Listerine

    8.5 FL OZ (250 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-664
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.92 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.42 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.60 mg  in 1 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55316-664-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:55316-664-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:55316-664-69 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 02/05/2008
    Labeler - DZA Brands LLC (090322194)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(55316-664)
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