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

  • NDC Code(s): 69892-664-19, 69892-664-77
  • Packager: Rockland Cosmetics, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

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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 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 ingredients

    water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

  • Adverse Reactions & Disclaimer

    Distributed By: Rockland Cosmetics, Inc.

    Hillburn, NY

    www.RocklandCosmetics.com

    Made in the U.S.A. with U.S. and foreign components.

    New Square Kashrus

    DSP-TN-21091

    DSP-MO-20087

  • Principle Panel Display

    SEALED WITH PRINTED NACKBAND FOR YOUR PROTECTION

    mint'evo

    EVOLUTIONIZING ORAL FRESHNESS

    ANTISEPTIC MOUTHWASH

    ANTIGINGIVITIS/ANIPLAQUE

    KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND GINGIVITIS GUM DISEASE

    BLUE MINT

    500mL (1.05 PT) 16.9 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69892-664
    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 SALICYLATE0.6 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)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69892-664-1994 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2024
    2NDC:69892-664-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/15/2024
    Labeler - Rockland Cosmetics, Inc. (027966560)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(69892-664)
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