YUMAKI ORIGINAL MINT TOOTH- xylitol, green tea leaf, ascorbic acid, levomenthol, peppermint, aminocaproic acid, water paste, dentifrice
Jeno And Company

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.

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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

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
Glycerin (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/01/2017

Labeler - Jeno And Company (688740221)

Registrant - Jeno And Company (688740221)

Name	Address	ID/FEI	Business Operations
Establishment
Jeno And Company		688740221	manufacture(71746-010)