Active Ingredient
Sodium Fluoride 0.22%(1,000 ppm fluoride ion)
O Bits Xylitol Toothpaste Fresh Mint Flavor
FDA Label NDC 82989-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Project Noah Inc. for the product O Bits Xylitol Toothpaste Fresh Mint Flavor (NDC 82989-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
