SMILE DIRECT CLUB- sodium fluoride 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 and Usage Section

Aids in the prevention of dental cavities.

Warnings

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

Keep out of Reach of Children

Keep out of reach of children under 6 year 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, Menthol, Stevia Rebaudiana Extract, Carrageenan.

Questions?

800-957-3409

Principle package label

Primary Packaging - Carton

INGREDIENTS AND APPEARANCE

SMILE DIRECT CLUB 
sodium fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73333-125
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MINT (UNII: FV98Z8GITP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SORBITOL (UNII: 506T60A25R)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT (Cool Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73333-125-02	1 in 1 CARTON	09/25/2019
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	09/25/2019

Labeler - Nutrix International, LLC (117341868)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrix,LLC		079833114	manufacture(73333-125)