TARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [FOODHOLD U.S.A., LLC]

TARTAR CONTROL PLUS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [FOODHOLD U.S.A., LLC]
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NDC 41520-434-86
Set ID 989fc576-fc65-48be-890c-d5ebad723ae8
Category HUMAN OTC DRUG LABEL
Packager Foodhold U.S.A., LLC
Generic Name
Product Class
Product Number
Application Number PART356
  • 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 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

    FOODHOLD U.S.A.,LLC

    LANDOVER, MD 20785

    1-877-846-9949

    2013 S&S Brands, LLC

    Quality guaranteed or money back

    DSP-TN-15000

    DSP-MO-34

    SDS-TN-15012

    434.000/434AA-AB

  • principal display panel

    Compare to Listerine Ultraclean With Everfresh Technolog-Arctic Mint

    CARE ONE

    TARTAR CONTROL

    PLUS

    ANTISEPTIC

    MOUTH RINSE

    Antigingivitis/Antiplaque

    ICEBERG BLUE FLAVOR

    • Helps fight tartar buildup
    • Long Lasting clean feel
    • Kills germs that cause Bad Breath, Plaque & the gum disease Gingivitis

    1 LITER

    (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:41520-434
    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:41520-434-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/06/2013
    Labeler - Foodhold U.S.A., LLC (809183973)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41520-434)

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