Label: O BITS XYLITOL TOOTHPASTE YUJA MINT FLAVOR- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 82989-020-01, 82989-020-02 - 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 September 23, 2022
If you are a consumer or patient please visit this version.
- 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, 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
- O-Bits Xylitol Toothpaste Yuja Mint Flavor (180 tablets)NDC: 82989-020-02
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INGREDIENTS AND APPEARANCE
O BITS XYLITOL TOOTHPASTE YUJA MINT FLAVOR
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82989-020 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:82989-020-01 30 in 1 CELLO PACK; Type 0: Not a Combination Product 09/01/2022 2 NDC:82989-020-02 180 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(82989-020)
