MINT DENTISTRY- charcoal spearmint paste
Nutrix International, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mint Dentistry - Charcoal Sexy teeth

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

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 Tube

Package

Front Package

MINT DENTISTRY
charcoal spearmint paste

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

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

Ingredient Name	Strength
Inactive Ingredients
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
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	1.8532 g in 113 g
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)	0.565 g in 113 g
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
SORBITOL (UNII: 506T60A25R)	24.86 g in 113 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

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

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

Labeler - Nutrix International, LLC. (117341868)

Registrant - Nutrix International, LLC. (117341868)

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