MINT DENTISTRY- charcoal spearmint paste

Mint Dentistry by

Drug Labeling and Warnings

Mint Dentistry by is a Otc medication manufactured, distributed, or labeled by Nutrix International, LLC., Nutrix International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium fluoride 0.24%

(0.15%w/v fluoride ion)

PURPOSE

Anticavity

INDICATIONS AND USAGE

Aids in the prevention of dental decay.

WARNING

As with all fluoride toothpaste, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

KEEP OUT OF REACH SECTION

Keep out of reach of children under 6 years of age.

DIRECTIONS

Adults and children 2 years and over: Brush teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of age: Use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). For children under 2 years of age: Ask a dentist or doctor.

INACTIVE INGREDIENTS

Glycerin, Sorbitol, Hydrated Silicas, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Mentha Viridis (Spearmint) Leaf Oil, Stevia Rebaudiana Leaf /Steam Extract, Xanthan Gum, Activated Charcoal.

QUESTIONS?

Call 833.879.6468

Dosage and Administration

Use a pea-sized amount via oral

Package

INGREDIENTS AND APPEARANCE

MINT DENTISTRY 
charcoal spearmint paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73333-115
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2938 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)	11.3 g  in 113 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.452 g  in 113 g
SPEARMINT OIL (UNII: C3M81465G5)	1.469 g  in 113 g
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)	0.3955 g  in 113 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	23.73 g  in 113 g
GLYCERIN (UNII: PDC6A3C0OX)	31.753 g  in 113 g
WATER (UNII: 059QF0KO0R)	16.3285 g  in 113 g
SORBITOL (UNII: 506T60A25R)	24.86 g  in 113 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	1.8532 g  in 113 g
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)	0.565 g  in 113 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73333-115-01	113 g in 1 TUBE; Type 0: Not a Combination Product	04/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/19/2020

Labeler - Nutrix International, LLC. (117341868)

Registrant - Nutrix International, LLC. (117341868)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrix International, LLC		117341868	manufacture(73333-115) , pack(73333-115) , label(73333-115)