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

  • NDC Code(s): 69968-0400-1, 69968-0400-2, 69968-0400-3, 69968-0400-5, view more
    69968-0400-9
  • Packager: Johnson & Johnson Consumer 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 April 1, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Eucalyptol (0.092%)Antiplaque/antigingivitis
    Menthol (0.042%)Antiplaque/antigingivitis
    Methyl Salicylate (0.060%)Antiplaque/antigingivitis
    Thymol (0.064%)Antiplaque/antigingivitis
  • Use

    helps prevent and reduce:

    • plaque
    • gingivitis
  • 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.

  • Directions

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

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

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

  • Questions?

    call toll-free 888-222-0182 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label

    ANTISEPTIC
    LISTERINE®
    ORIGINAL

    FOR A FRESHER &
    CLEANER MOUTH THAN
    BRUSHING ALONE

    ADA
    Accepted
    American
    Dental
    Association®

    1.5 L (1 Qt 1 Pt 2.7 Fl Oz)

    PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE   ORIGINAL ANTISEPTIC
    eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK) Eucalyptol0.92 mg  in 1 mL
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form0.42 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)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Caramel (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0400-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
    2NDC:69968-0400-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
    3NDC:69968-0400-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
    4NDC:69968-0400-11500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
    5NDC:69968-0400-995 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/06/2019
    Labeler - Johnson & Johnson Consumer Inc. (002347102)