FLUORIDE BITS- sodium monofluorophosphate 0.76% tablet

Fluoride Bits by

Drug Labeling and Warnings

Fluoride Bits by is a Otc medication manufactured, distributed, or labeled by The Kind Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.76 % (0.14% w/w fluoride ion)

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.

Keep out of reach of children under 6 yrs 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 atleast 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.

QUESTIONS

BiteToothpaste.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUORIDE BITS 
sodium monofluorophosphate 0.76% tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82976-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
MENTHOL (UNII: L7T10EIP3A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
CALCIUM CARBONATE (UNII: H0G9379FGK)
PEPPERMINT (UNII: V95R5KMY2B)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ZINC CITRATE (UNII: K72I3DEX9B)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GUAR GUM (UNII: E89I1637KE)

Product Characteristics
Color	white (White to Off White)	Score	score with uneven pieces
Shape	ROUND	Size	6mm
Flavor	MINT	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82976-100-02	124 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/06/2022
2	NDC: 82976-100-00	124 in 1 POUCH; Type 0: Not a Combination Product	12/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/06/2022

Labeler - The Kind Lab, Inc. (117339209)