FLUORIDE- sodium fluoride tablet

FLUORIDE by

Drug Labeling and Warnings

FLUORIDE by is a Otc medication manufactured, distributed, or labeled by Mintly Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.21% (0.30 mg fluoride ion)

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental cavities

Warnings

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.

Directions

• Adults and children 2 years of age and older: chew tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.
• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
• Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

Other information

Store at 68-77°F (20-25°C).

Protect from excessive moisture.

Inactive ingredients

microcrystalline cellulose, sodium bicarbonate, silica, sodium lauroyl glutamate, magnesium stearate, natural mint flavor, menthol, xanthan gum, stevioside, citric acid

Questions?

Call 888-478-6710

SPL UNCLASSIFIED SECTION

DIST. BY MINTLY INC., PRINCETON, NJ 08540

PRINCIPAL DISPLAY PANEL - 240 Tablet Jar Label

mintly

TOOTHPASTE
TABLETS

with fluoride

NATURAL MINT

240
TABLETS

2.6 OZ (74.9g)

INGREDIENTS AND APPEARANCE

FLUORIDE 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82149-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	Sodium Fluoride	0.6552 mg

Inactive Ingredients
Ingredient Name	Strength
Microcrystalline Cellulose (UNII: OP1R32D61U)
Sodium Bicarbonate (UNII: 8MDF5V39QO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Sodium Lauroyl Glutamate (UNII: NCX1UU2D33)
Magnesium Stearate (UNII: 70097M6I30)
Mint (UNII: FV98Z8GITP)
MENTHOL, (+)- (UNII: C6B1OE8P3W)
Xanthan Gum (UNII: TTV12P4NEE)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	9mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82149-001-01	60 in 1 JAR; Type 0: Not a Combination Product	08/30/2021
2	NDC: 82149-001-02	240 in 1 JAR; Type 0: Not a Combination Product	08/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	08/30/2021

Labeler - Mintly Inc. (118220595)