Label: TARTAR CONTROL PLUS- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 0869-0434-12, 0869-0434-13, 0869-0434-69, 0869-0434-77, view more
    0869-0434-86
  • Packager: Vi-Jon, 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 7, 2022

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

  • 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 6 years to under 12 years of age - supervise use

    children under 6 years of age - do not use

    • 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°-86°F)

  • Inactive ingredients

     water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, blue 1

  • Disclaimer

    This product is not manufactured or distribted by Johnson & Johnson Healthcare Products, distributor of Listerine Ultraclean With Everfresh Technology - Artic Mint.

  • Adverse Reactions

    Distributed by:

    Vi-Jon, LLC

    One Swan Drive

    Smyrna, TN 37167

    DSP-TN-15000

    DSP-M-34

    SDS-TN-15012

  • principal display panel

    mountain

    falls

    Compare

    to Listerine

    controls

    tartar

    long

    lasting

    clean

    feel

    kills gerns

    plaque &

    gingivitis

    fights

    bad

    breath

    tartar control plus

    antiseptic

    mouth rinse

    antigingivitis/antiplaque mouth rinse

    iceberg blue

    1.5 L (50.7 FL OZ)

    image description

  • principal display panel

    Sealed With Printed Neckband For Your Protection

    Swan

    TARTAR CONTROL

    PLUS

    Antiseptic Mouth Rinse

    Antigingivitis/Antiplaque

    icebeg blue

    Kills germs that cause Bad Breath, Plaque + the gum disease Gingivitis

    Compare to Listerine Ultraclean With Everfresh Technology - Artic Mint

    1 Litter (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    TARTAR CONTROL PLUS 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0434
    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)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0434-121499 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2013
    2NDC:0869-0434-131251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2013
    3NDC:0869-0434-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2013
    4NDC:0869-0434-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2013
    5NDC:0869-0434-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/10/2013
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0434)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0434)