YUMAKI ORIGINAL MINT TOOTH: Package Insert and Label Information

YUMAKI ORIGINAL MINT TOOTH- xylitol, green tea leaf, ascorbic acid, levomenthol, peppermint oil, aminocaproic acid and 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.

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XYLITOL (XYLITOL) XYLITOL 0.1 g in 100 g GREEN TEA LEAF (GREEN TEA LEAF) GREEN TEA LEAF 0.1 g in 100 g ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 0.005 g in 100 g LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 0.1 g in 100 g PEPPERMINT OIL (PEPPERMINT) PEPPERMINT OIL 0.05 g in 100 g AMINOCAPROIC ACID (AMINOCAPROIC ACID) AMINOCAPROIC ACID 0.05 g in 100 g WATER (WATER) WATER 45.15 g in 100 g

Inactive Ingredients Ingredient Name Strength Glycerin

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71746-010-02 1 TUBE in 1 CARTON contains a TUBE (71746-010-01) 1 NDC:71746-010-01 100 g in 1 TUBE This package is contained within the CARTON (71746-010-02)

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	Operations
Jeno And Company		688740221	manufacture (71746-010)

Revised: 12/2017 Jeno And Company