Label: ANTISEPTIC MOUTH RINSE- eucalyptol mouthwash

  • NDC Code(s): 11822-0072-1, 11822-0072-2
  • 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 January 31, 2022

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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 (59⁰ - 77⁰F)

  • Inactive ingredients

    water, alcohol 21.6%, sorbitol {solution}, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no. 3

  • Disclaimer

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

  • Adverse reaction

    DISTRIBUTED BY

    Rite Aid

    30 Hunter Lane, camp Hill, PA 17011

    Learn more at www.RiteAid.com

  • principal display panel

    Sealed with printed neckband for your protection

    Compare to FreshBurst Listerine Antiseptic Mouthwash

    ANTISEPTIC

    MOUTHWASH

    ANTIGINGIVITIS/ANTIPLAQUE RINSE

    FRESH MINT

    helps reduce plaque & gingivitis

    fights bad breath

    child-resistant cap

    ADA

    Accepted

    American

    Dental

    Association

    • Helps reduce plaque
    • Helps reduce gingivitis

    RITE

    AID

    PHARMACY

    1L (1.05 QT) 33.8 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0072
    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)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0072-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/1997
    2NDC:11822-0072-21500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/1997
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11822-0072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11822-0072)
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