Label: DR.NOAH SOLIDTOOTHPASTE- sodium fluoride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 82359-0003-1, 82359-0003-2 - Packager: DR.Noah
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated October 29, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
D-Sorbitol,Microcrystalline Cellulose, Xylitol, Enzymatically Modified Stevia, Bamboo Salt, L-Menthol, CombinedFlavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(SperamintFlavor Powder), Yuzu Extract, Chamomile Powder, Sodium Bicarbonate, Xanthan Gum,Hydroxypropylcellulose, Magnesium Stearate, Sodium Cocoyl Glutamate
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNING
- USES
- INDICATION & USAGE SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR.NOAH SOLIDTOOTHPASTE
sodium fluoride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82359-0003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.00154 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 0.035 g SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE 0.007 g PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 0.00035 g Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white Score score with uneven pieces Shape ROUND Size 12mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82359-0003-1 180 in 1 POUCH; Type 0: Not a Combination Product 10/29/2021 2 NDC:82359-0003-2 30 in 1 CASE; Type 0: Not a Combination Product 10/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/29/2021 Labeler - DR.Noah (695333875) Registrant - DR.Noah (695333875) Establishment Name Address ID/FEI Business Operations SUNGWON PHARMACEUTICAL CO., LTD. 689787898 manufacture(82359-0003) Establishment Name Address ID/FEI Business Operations DR.Noah 695333875 label(82359-0003)