Label: ANTISEPTIC MOUTHRINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 72288-072-12, 72288-072-69, 72288-072-86
  • Packager: Amazon.Com Services LLC
  • 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 15, 2022

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  • Active ingredients

    Eucalyptol 0.092%, Menthol 0.042%, Methyl sailcylate 0.060%, Thymol 0.064%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    Helps control plaque that leads to gingivitis

  • WARNINGS

    Warnings

  • Do not use if

    you have painful or swollen gums, pus from the gum line, loose teeth or incresed 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 rednss 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 under 12 years if 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 propeties are not affected.  Store at room temperature (59° -77° F)

  • 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

  • SPL UNCLASSIFIED SECTION

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

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

    Distributed by: Amazon.com Services, LLC

    Seattle, WA 98109  1-877-485-0385

    Amazon

    2021 Amazon.com, Inc. or its affiliates.

    All rights reserved.

    www.amzon.com/amazonasics

    "Alexa, reorder Amazon Basics Mouthwash"

  • principal display panel

    amazonbasics

    antiseptic

    mouthwash

    Antigingivitis/Antiplaque

    Spring Mint Flavor

    Compare to Fresh Burst Listerine Antiseptic Mouthwash

    33.8 FL OZ (1 L)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTHRINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-072
    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:72288-072-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2018
    2NDC:72288-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2018
    3NDC:72288-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/05/2018
    Labeler - Amazon.Com Services LLC (128990418)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72288-072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(72288-072)
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