O BITS XYLITOL TOOTHPASTE YUJA MINT FLAVOR- 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, Xylitol(50,000 ppm), Silicon Dioxide, Sodium Cocoyl Glutamate, Microcrystalline Cellulose, Xanthan Gum, Tetrasodium Pyrophosphate, Sodium Bicarbonate, Magnesium Stearate, Combined Flavor(Strongmint Flavor), Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Spearmint Flavor Powder), Hydroxypropylcellulose, Gardenia Yellow, Gardenia Blue, Enzymatically Modified Stevia, Bamboo Salt, Yuja Extract, Sage Extract, Pyridoxine Hydrochloride, L-Menthol

O-Bits Xylitol Toothpaste Yuja Mint Flavor (30 tablets)
NDC: 82989-020-01

Image of cello pack

O-Bits Xylitol Toothpaste Yuja Mint Flavor (180 tablets)
NDC: 82989-020-02

Image of cello pack

O BITS XYLITOL TOOTHPASTE YUJA MINT FLAVOR 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82989-020
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)  
Xylitol (UNII: VCQ006KQ1E)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82989-020-0130 in 1 CELLO PACK; Type 0: Not a Combination Product09/01/2022
2NDC:82989-020-02180 in 1 CELLO PACK; Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2022
Labeler - Project Noah Inc. (694208735)
Registrant - Project Noah Inc. (694208735)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(82989-020)

Revised: 9/2022
Document Id: ad0cec91-cc1d-4cc2-8118-d05c3434326d
Set id: cb4b3ffa-4e9c-4fe5-ac2c-edbbcf24dbb0
Version: 2
Effective Time: 20220923
 
Project Noah Inc.