Label: MOUTH RINSE- eucalyptol, menthol, methylsalicylate, thymol mouthwash

  • 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 26, 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, poloxamer 407, benzoic acid, sodium saccharin,  flavor, sodium citrate, yellow 10,  green 3

  • questions or comments? 

    1-800-632-6900

  • ADA council statement

    The ADA Council on Scientific Affairs' Acceptance of Kroger Mint  Burst Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

  • Disclaimer

    Listerine is a registred trademark of Johnson & Johnson Healthcare Products, New Brunswick, NJ 08903.  Johnson & Johnson Healthcare Products is not affiliated with The Kroger Co. or this product.

  • Adverse Reactions

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OH 45202

    QUALITY GUARANTEE

    800-632-6900  www.kroger.com

  • principal display panel

    COMPARE to the active ingredients of LISTERINE * See back label

    Kroger

    FROM OUR FAMILY TO YOURS

    Mint Burst

    ANTISEPTIC

    MOUTH RINSE

    ANTGINGIVITIS/ANTIPLAQUE

    • Kills Germs That Cause Bad Breath, Plaque & the Gum Disease Gingivitis
    • For Fresher Breath

    ADA

    Accepted

    American

    Dental

    Association

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    16.9 FL OZ (500 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    MOUTH RINSE 
    eucalyptol, menthol, methylsalicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-072
    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
    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:30142-072-77500 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package11/11/1989
    2NDC:30142-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/11/1989
    Labeler - Kroger (006999528)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(30142-072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(30142-072)
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