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

  • NDC Code(s): 42002-401-63, 42002-401-70, 42002-401-71, 42002-401-72, view more
    42002-401-73, 42002-401-94, 42002-401-95
  • Packager: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
  • 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 February 23, 2012

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purposes
    Eucalyptol 0.092% }
    Menthol 0.042% }
    Methyl salicylate 0.060% }
    Thymol 0.064% }
    Antiplaque/antigingivitis
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  • Uses

    helps prevent and reduce:

    • plaque
    • gingivitis
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  • Warnings

    Do not use in children under 12 years of age

    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

    • rinse full strength for 30 seconds with 20 ml (2/3 fluid ounce or 4 teaspoonfuls) morning and night
    • do not swallow
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  • Other information

    • store at room temperature
    • cold weather may cloud this product. Its antiseptic properties are not affected.
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  • Inactive ingredients

    water, alcohol (26.9%), benzoic acid, poloxamer 407, sodium benzoate, caramel

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  • Questions?

    call 1-888-222-0182, weekdays

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  • SPL UNCLASSIFIED SECTION

    Dist: Johnson & Johnson Healthcare Products
    Division of McNEIL-PPC, Inc.
    Skillman, NJ 08558-9418 USA

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  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    LISTERINE®
    ORIGINAL
    ANTISEPTIC

    Kills Germs that Cause
    Bad Breath, Plaque & the
    Gum Disease Gingivitis

    ADA
    Accepted
    American
    Dental
    Association®

    500 mL (1.05 Pt)

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    LISTERINE ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, and thymol mouthwash
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-401
    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) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate 0.6 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)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Caramel (UNII: T9D99G2B1R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42002-401-73 250 mL in 1 BOTTLE, PLASTIC
    2 NDC:42002-401-72 500 mL in 1 BOTTLE, PLASTIC
    3 NDC:42002-401-71 1000 mL in 1 BOTTLE, PLASTIC
    4 NDC:42002-401-70 1500 mL in 1 BOTTLE, PLASTIC
    5 NDC:42002-401-63 3700 mL in 1 BOTTLE, PLASTIC
    6 NDC:42002-401-94 2 in 1 PACKAGE
    6 NDC:42002-401-70 1500 mL in 1 BOTTLE, PLASTIC
    7 NDC:42002-401-95 95 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 02/21/2012
    Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)
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