Label: LISTERINE ULTRACLEAN ARCTIC MINT- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash

  • NDC Code(s): 69968-0399-1, 69968-0399-2, 69968-0399-3, 69968-0399-4, view more
    69968-0399-8, 69968-0399-9
  • 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 September 3, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Eucalyptol(0.092%)
    Menthol (0.042%)
    Methyl Salicylate (0.060%)
    Thymol (0.064%)

  • Purposes

    Antiplaque/antigingivitis

  • Uses

    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 20 mL (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(21.6%), Sorbitol, Poloxamer 407, Flavor, Benzoic Acid, Zinc Chloride, Sodium Benzoate, Sucralose, Sodium Saccharin, Blue 1

  • 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 - 500 mL Bottle Label

    ANTISEPTIC
    LISTERINE ®
    ULTRACLEAN

    FOR UP TO A 3X
    LONGER LASTING
    CLEAN FEELING*

    *vs. brushing alone

    ARCTIC MINT ®

    500 mL (1.05 Pt)

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE ULTRACLEAN ARCTIC MINT 
    eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0399
    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)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0399-395 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2012
    2NDC:69968-0399-8250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2012
    3NDC:69968-0399-9500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2012
    4NDC:69968-0399-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2012
    5NDC:69968-0399-21500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2012
    6NDC:69968-0399-42 in 1 PACKAGE07/03/2012
    6NDC:69968-0399-21500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/03/2012
    Labeler - Johnson & Johnson Consumer Inc. (002347102)
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