Label: YUMAKI ORIGINAL MINT TOOTH- xylitol, green tea leaf, ascorbic acid, levomenthol, peppermint, aminocaproic acid, water paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 7, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Xylitol 0.1%, Green tea Extract 0.1%, Vitamin C 0.005%, L-Menthol 0.1%, Mint oil 0.05%, Aminocaproic Acid 0.02%, Pure water 45.15%

  • INACTIVE INGREDIENT

    Inactive ingredients: GLYCERIN, SILICA, MENTHA, ARVENSIS LEAFOIL SORBITOL, DIBASIC CALCIUM PHOSPHATE

  • PURPOSE

    Purpose: Protect Teeth, Anti-Gingivitis, Multi Action Formula, Strengthen Enamel, Cavity Fighting, Extra Fresh Breath

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: Helps protect against cavities

  • Directions

    Directions:

    1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor.

    2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.

    3) Children under 2 years: Consult a dentist or doctor.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    YUMAKI ORIGINAL MINT TOOTH 
    xylitol, green tea leaf, ascorbic acid, levomenthol, peppermint, aminocaproic acid, water paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71746-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL0.1 g  in 100 g
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF0.1 g  in 100 g
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID0.005 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL0.1 g  in 100 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.05 g  in 100 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.05 g  in 100 g
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER45.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71746-010-021 in 1 CARTON11/01/2017
    1NDC:71746-010-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2017
    Labeler - Jeno And Company (688740221)
    Registrant - Jeno And Company (688740221)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jeno And Company688740221manufacture(71746-010)
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