Label: INNOBLE ONECHEWTOOTHPASTE- sodium fluoride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 82709-001-01, 82709-001-02, 82709-001-03 - Packager: livmate
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 4, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
D-Sorbitol, Sodium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Microcrystalline Cellulose, Xylitol, Magnesium Stearate, Sodium Bicarbonate, Xanthan Gum, Hydroxypropylcellulose, Enzymatically Modified Stevia, L-Menthol, Bamboo Salt, Sodium Chloride, DL-Malic Acid, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Coconut Oil, Aloe Vera Gel, Carrot Extract, Calendula Extract
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNING
- Directions
- INDICATION & USAGE SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INNOBLE ONECHEWTOOTHPASTE
sodium fluoride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82709-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.22 g in 100 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 5 g in 100 g SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE 1 g in 100 g PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 0.05 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) XYLITOL (UNII: VCQ006KQ1E) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM BICARBONATE (UNII: 8MDF5V39QO) XANTHAN GUM (UNII: TTV12P4NEE) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) LEVOMENTHOL (UNII: BZ1R15MTK7) SODIUM CHLORIDE (UNII: 451W47IQ8X) MALIC ACID (UNII: 817L1N4CKP) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARROT (UNII: L56Z1JK48B) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82709-001-01 84 g in 1 POUCH; Type 0: Not a Combination Product 05/03/2022 2 NDC:82709-001-03 1 in 1 CARTON 05/03/2022 2 NDC:82709-001-02 42 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/03/2022 Labeler - livmate (987587873) Registrant - livmate (987587873) Establishment Name Address ID/FEI Business Operations SUNGWON PHARMACEUTICAL CO., LTD. 689787898 manufacture(82709-001)
