SMILE DIRECT CLUB- sensitivity toothpaste paste, dentifrice 
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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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

Primary Packaging Tube

Packaging Label - Carton

Packaging Carton

SMILE DIRECT CLUB 
sensitivity toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73333-126
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73333-126-021 in 1 CARTON11/22/2019
1125 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/22/2019
Labeler - Nutrix International, LLC (117341868)
Establishment
NameAddressID/FEIBusiness Operations
Nutrix, LLC079833114manufacture(73333-126)

Revised: 1/2020
Document Id: 9c48a724-8004-2470-e053-2995a90a6365
Set id: 9c48a5ef-9f97-95ee-e053-2995a90a271f
Version: 2
Effective Time: 20200116
 
Nutrix International, LLC