OTC Medication Information: O Bits Xylitol Toothpaste Yuja Mint Flavor

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.

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
(click image for full-size original)

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

Image of cello pack
(click image for full-size original)

O BITS XYLITOL TOOTHPASTE YUJA MINT FLAVOR
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82989-020
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (FLUORIDE ION) FLUORIDE ION 0.22 g in 100
Inactive Ingredients
Ingredient Name Strength
SORBITOL
Xylitol
Silicon Dioxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82989-020-01 30 PASTE, DENTIFRICE in 1 CELLO PACK None
2 NDC:82989-020-02 180 PASTE, DENTIFRICE in 1 CELLO PACK None
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 Operations
Sungwon Pharmaceutical Co., Ltd. 689787898 manufacture (82989-020)

Revised: 09/2022 Project Noah Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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