DR.NOAH TOOTHPASTE TABLETS- sodium fluoride paste, dentifrice 
Project Noah Inc.

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.

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ACTIVE INGREDIENT

Sodium Fluoride 0.22%(1,000 ppm fluoride ion)

PURPOSE

Anti-cavity

Uses

■ Helps protect against cavities, plaque, and gingivitis.

Warnings

Please keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children under 6 years of age

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

■ Store at 33.8-86℉(1-30°C)

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

Image of cello pack

Dr.NOAH Toothpaste Tablets (180 TABLETS)
NDC: 82989-030-02

Image of cello pack

DR.NOAH TOOTHPASTE TABLETS 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82989-030
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82989-030-0130 in 1 CELLO PACK; Type 0: Not a Combination Product10/01/2022
2NDC:82989-030-02180 in 1 CELLO PACK; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/2022
Labeler - Project Noah Inc. (694208735)
Registrant - Project Noah Inc. (694208735)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(82989-030)

Revised: 10/2022
Document Id: af0685db-7b12-42c3-9f8a-99c74dbef590
Set id: 3fec6cda-62cc-4e13-a100-1411681c5bbc
Version: 1
Effective Time: 20221013
 
Project Noah Inc.