NDC | 67225-0009-1 |
Set ID | e2263f8a-c354-4a3d-8e06-f1f3bbdef79f |
Category | HUMAN OTC DRUG LABEL |
Packager | Aekyung Industrial Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART332 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
-
DOSAGE & ADMINISTRATION
Do not swallow. Rinse mouth with water after brushing.
Children under 6 years:
- To minimize swallowing, use a pea-sized amount. Supervise brushing until good habits are established.
- If swallowed more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.
- INDICATIONS & USAGE
- INSTRUCTIONS FOR USE
- DO NOT USE
- STORAGE AND HANDLING
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
INACTIVE INGREDIENT
Inactive Ingredients: Liquid Sorbitol (Non-crystalizing), Glycerin, Polyethylene Glycol 1500, Sodium Alginate, Trisodium Citrate, Saccharin Sodium Hydrate, Cocamidopropyl Betain, Sodium Lauryl Sulfate, Sodium N-Cocoyl-N-Methyl Taurate Solution, Titanium Dioxide, Thymus Vulgaris (Thyme) Leaf Extract, Cymbopogon Citratus Extract, Pelargonium Graveolens Extract, Cinnamonium Zeylanicum Bark Extract, Foenlculum Vulgare (Fennel) Seed Extract, Rosemarinus Officinalis (Rosemary) Leaf Extract, Eugenia Caryphyllus (Clove) Flower Extract, Purified Water
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
2080 DENTISTRY NIGHT FRESH
dental type silica (silicon dioxide), zinc citrate, trihydrate, cetylpyridinium chloride, dipotassium glycyrrhizinate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67225-0009 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 15 g in 100 g Inactive Ingredients Ingredient Name Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) ZINC CITRATE TRIHYDRATE (UNII: GNM26GAX7R) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) THYMUS VULGARIS LEAF (UNII: GRX3499643) CYMBOPOGON CITRATUS WHOLE (UNII: 6AE8LT94NG) PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F) CINNAMON BARK OIL (UNII: XE54U569EC) FENNEL SEED (UNII: G3QC02NIE6) ROSEMARY (UNII: IJ67X351P9) CLOVE (UNII: K48IKT5321) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67225-0009-1 1 in 1 CARTON 02/03/2017 1 100 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 OTC monograph final part332 02/03/2017 Labeler - Aekyung Industrial Co., Ltd. (687995647) Establishment Name Address ID/FEI Business Operations Aekyung Ind. Co., Ltd._Chungyang Factory 690511126 manufacture(67225-0009)