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

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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%

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  • INACTIVE INGREDIENT

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

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  • PURPOSE

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

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • Uses

    Uses: Helps protect against cavities

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  • 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.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    YUMAKI ORIGINAL MINT TOOTH 
    xylitol, green tea leaf, ascorbic acid, levomenthol, peppermint, aminocaproic acid, water paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71746-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL 0.1 g  in 100 g
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF 0.1 g  in 100 g
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 0.005 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 0.1 g  in 100 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL 0.05 g  in 100 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID 0.05 g  in 100 g
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 45.15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71746-010-02 1 in 1 CARTON 11/01/2017
    1 NDC:71746-010-01 100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/01/2017
    Labeler - Jeno And Company (688740221)
    Registrant - Jeno And Company (688740221)
    Establishment
    Name Address ID/FEI Business Operations
    Jeno And Company 688740221 manufacture(71746-010)
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