NDC | 71746-010-01, 71746-010-02 |
Set ID | e9e39848-2f71-4f32-8bed-b41fc80c5145 |
Category | HUMAN OTC DRUG LABEL |
Packager | Jeno And Company |
Generic Name | |
Product Class | Antifibrinolytic Agent |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
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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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
YUMAKI ORIGINAL MINT TOOTH
xylitol, green tea leaf, ascorbic acid, levomenthol, peppermint, aminocaproic acid, water paste, dentifriceProduct 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)