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.
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%Close
- INACTIVE INGREDIENT
Inactive ingredients: GLYCERIN, SILICA, MENTHA, ARVENSIS LEAFOIL SORBITOL, DIBASIC CALCIUM PHOSPHATEClose
Purpose: Protect Teeth, Anti-Gingivitis, Multi Action Formula, Strengthen Enamel, Cavity Fighting, Extra Fresh BreathClose
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.Close
- KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDRENClose
Uses: Helps protect against cavitiesClose
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.Close
- 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)