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

  • NDC Code(s): 71746-010-01, 71746-010-02
  • Packager: Jeno And Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 7, 2017

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

  • 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)