Label: DR.NOAH TOOTHPASTE TABLETS- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 82989-030-01, 82989-030-02 - Packager: Project Noah Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 13, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
■ Adults and children 6 years of age and older: Chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 6 years of age: Do not use unless directed by a dentist or doctor.
- Other Information
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Inactive ingredients
D-Sorbitol, Silicon Dioxide, Sodium Cocoyl Glutamate, Xylitol, Tetrasodium Pyrophosphate, Microcrystalline Cellulose, Xanthan Gum, Sodium Bicarbonate, Magnesium Stearate, Enzymatically Modified Stevia, Hydroxypropylcellulose, Yuzu Extract, Sage Extract, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(Spearmint Flavor Powder), L-Menthol, Bamboo Salt, Pyridoxine Hydrochloride
- Dr.NOAH Toothpaste Tablets (30 TABLETS)NDC: 82989-030-01
- Dr.NOAH Toothpaste Tablets (180 TABLETS)NDC: 82989-030-02
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INGREDIENTS AND APPEARANCE
DR.NOAH TOOTHPASTE TABLETS
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82989-030 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 Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82989-030-01 30 in 1 CELLO PACK; Type 0: Not a Combination Product 10/01/2022 2 NDC:82989-030-02 180 in 1 CELLO PACK; Type 0: Not a Combination Product 10/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/01/2022 Labeler - Project Noah Inc. (694208735) Registrant - Project Noah Inc. (694208735) Establishment Name Address ID/FEI Business Operations Sungwon Pharmaceutical Co., Ltd. 689787898 manufacture(82989-030)