Label: ORAL CARE ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 11822-3108-0, 11822-3108-2
  • Packager: Rite Aid
  • 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 June 8, 2023

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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

    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
  • 0ther information

    cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

  • Inactive ingredients

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

  • Disclaimer

    *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Antiseptic Mouthwash.

  • Caims

    OUR PROMISE:

    Gluten Free

    Sugar Free

    Paraben Free

  • Adverse Reaction

    DISTRIBUTED BY:

    RITE AID, 30 Hunter Lane,

    Camp Hill, PA 17011

    www.Riteaid.com

    SATISFACTION GUARANTEE

    If you're not satisfied, we'll happily refund your money.

  • Principal display panel

    Sealed with printed neckband for your protection

    Compare to Original Listerine Antiseptic Mouthwash*

    FREE FROM 

    GLUTEN FREE

    SUGAR FREE

    ANTISEPTIC 

    MOUTHWASH

    ANTIGINGIVITIS/ANTIPLAQUE RINSE

    ORIGINAL

    helps reduce plaque & gingivitis

    fights bad breath

    child-resistant cap

    ADA Accepted

    American Dental Association

    • Helps reduce plaque
    • Hepls reduce gingivitis

    1 L (1 QT 1.8 FL OZ) 33.8 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ORAL CARE ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3108
    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 SALICYLATE0.60 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:11822-3108-21000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/1990
    2NDC:11822-3108-0500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/15/1990
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11822-3108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11822-3108)
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