Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 71569-664-12, 71569-664-86
  • Packager: Jubilant, 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 January 9, 2023

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  • Active ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl salicylate 0.060%

    Thymol 0.064%

  • Purpose

    Antigingivitis, antiplaque

  • Use

    help 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 unmder 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 (59°-77°F)

  • Inactive ingredients

    water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, FD&C green no.3

  • SPL UNCLASSIFIED SECTION

    *This product us not manufactured or distributed by Johnson & Johnson Healthcare Products, distributer of Coll Mint Listerine Antiseptic Mouthwash.

    Distributed by:

    Jubilant LLC, Union, NJ 07083

    www.PrinceSpring.Com

    QUESTIONS? COMMENTS?

    Toll Free: (833) 588-2855

    Hi@PrinceSpring.com

    @princeandspring

    BROUGHT TO YOU BY BOXED

    DSP-TN-21091

    DSP-MO-20087

  • principal display panel

    PRINCE & SPRING

    ANTISEPTIC MOUTHWASH

    Blue Mint Flavored

    Kills 99.9% of Germs Commonly Associated with Gingivitis

    Fights Bad Breath

    Helps Reduce Plaque

    Contains 21.6% Alcohol

    1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71569-664
    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 BENZOATE (UNII: OJ245FE5EU)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71569-664-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2017
    2NDC:71569-664-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/03/2017
    Labeler - Jubilant, LLC (079508724)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(71569-664)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(71569-664)
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