SMILE DIRECT CLUB- sensitivity toothpaste paste, dentifrice

Smile Direct Club by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.24%

Purpose

Anticavity

Indications

Aids in the prevention of dental decay.

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach

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

Directions

- Adults and children 2 years of age and older. 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.

Inactive Ingredients

Sorbitol, Hydrated Silica, Water (Agua), Glycerin, Xylitol, Sodium Lauryl Sulfate, Flavor, Xanthan Gum,Titanium Dioxide, Stevia Rebaudiana Extract, Aloe Barbadensis Leaf Extract, Cocamidopropyl Betaine, Menthol.

Questions

800-957-3409

Primary Packaging Label

Packaging Label - Carton

INGREDIENTS AND APPEARANCE

SMILE DIRECT CLUB 
sensitivity toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73333-126
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM NITRATE (UNII: RU45X2JN0Z)
XYLITOL (UNII: VCQ006KQ1E)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
MENTHOL (UNII: L7T10EIP3A)
MINT (UNII: FV98Z8GITP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCONUT OIL (UNII: Q9L0O73W7L)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73333-126-02	1 in 1 CARTON	11/22/2019
1		125 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/22/2019

Labeler - Nutrix International, LLC (117341868)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrix, LLC		079833114	manufacture(73333-126)