Label: ANTISEPTIC MOUTH RINSE- eucalyptol. menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 41190-072-12, 41190-072-13, 41190-072-86
  • Packager: Wakefern Food Corporation
  • 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, 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

    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

  • SPL UNCLASSIFIED SECTION

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

    Distributed By:

    Wakefern Food Corp

    5000 Riverside Drive

    Keasbey, NJ 08832

    Satisfaction guaranteed or your money back

  • principal display panel

    Compare to the Active Ingredients of Listerine*

    ShopRite

    Antiseptic

    Mouth Rinse

    Helps to kill germs that cause plaque,gingivitis and bad breath

    FRESH MINT

    ADA Accepted

    American Dental Association

    Sealed With Printed Neckband For Your Protection

    1.5 L (50.7 FL OZ)

    image description

  • principal display panel

    COMPARE TO FRESH BURST LISTERINE*

    PRICE RITE

    Antiseptic MOUTHRINSE

    Antigingivitis/Antiplaque

    FRESH MINT

    Helps kill germs that cause plaque and gingivitis and bad breath

    SEALED WITH PREINTED NECKBAND FOR YOUR PROTECTION

    1L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTH RINSE 
    eucalyptol. menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-072
    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 SOLUTION (UNII: 8KW3E207O2)  
    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:41190-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/1999
    2NDC:41190-072-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/1999
    3NDC:41190-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/28/1999
    Labeler - Wakefern Food Corporation (069722418)
    Registrant - Vi-Jon, LLC (790752542)
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