O BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR- sodium fluoride paste, dentifrice

O Bits Xylitol Toothpaste Fresh Mint Flavor by

Drug Labeling and Warnings

O Bits Xylitol Toothpaste Fresh Mint Flavor by is a Otc medication manufactured, distributed, or labeled by Project Noah Inc., Sungwon Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Fresh Mint Flavor (30 tablets)NDC:

82989-010-01

O-Bits Xylitol Toothpaste Fresh Mint Flavor (180 tablets)NDC:

82989-010-02

INGREDIENTS AND APPEARANCE

O BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82989-010
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)
Xylitol (UNII: VCQ006KQ1E)
Silicon Dioxide (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82989-010-01	30 in 1 CELLO PACK; Type 0: Not a Combination Product	09/01/2022
2	NDC: 82989-010-02	180 in 1 CELLO PACK; Type 0: Not a Combination Product	09/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2022

Labeler - Project Noah Inc. (694208735)

Registrant - Project Noah Inc. (694208735)

Establishment
Name	Address	ID/FEI	Business Operations
Sungwon Pharmaceutical Co., Ltd.		689787898	manufacture(82989-010)