Otc - Active Ingredient
Sodium Monofluorophosphate 0.76 % (0.14 % w/w fluoride ion)
Fluoride Bits Tablet
FDA Label NDC 82976-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Kind Lab, Inc. for the product Fluoride Bits (NDC 82976-101). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anticavity
Indications & Usage
Helps protect against dental cavities
Warnings
If more than used for brushing is accidentally swallowed, get medical help or contact Poison Control Center right away. Keep away from pets.
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrenunder 6 years of age.
Dosage & Administration
Adult:
Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or at least twice daily or as directed by a dentist or physician.
Rinse after using.
Do not swallow.
Inactive Ingredient
Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.
Other Safety Information
Store at room temperature and in a dry place
Otc - Questions
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