Label: ANTISEPTIC MOUTH RINSE- eucalyptol mouthwash

  • NDC Code(s): 72036-072-77, 72036-072-86
  • Packager: HARRIS TEETER
  • 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 30, 2023

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

View All Sections
  • 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 you 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

    weather may cloud this product. It antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰F)

  • Inactive ingredients

    water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D&C yellow no. 1, FD&C green no. 3

  • SPL UNCLASSIFIED SECTION

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

    ADA Accepted

    American Dental Association

    • Helps reduce plaque
    • Helps reduce gingivitis

    Proudly distributed by:

    Harris Teeter, LLC, Matthews, NC 28105

    1-800-432-6111 or harristeeter.com

    DSP-TN-15000
    DSP-MO-34
    SDS-TN-15012

  • Principal Panel Display

    Sealed With Printed Neckband For your Protection

    Harris Teeter

    *Compare to FreshBurst Listerine Antiseptic

    FRESH MINT

    ANTISEPTIC MOUTH RINSE

    ANTIGINGIVITIS/ANTIPLAQUE

    • Kills germs
    • Fights bad breath

    1 LITER (33.8 FL OZ)

    TOGETEHR IN EDUCATION

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72036-072
    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
    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:72036-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/15/2009
    2NDC:72036-072-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/15/2009
    Labeler - HARRIS TEETER (047279351)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon088520668manufacture(72036-072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture(72036-072)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!