SMILE DIRECT CLUB- sodium fluoride 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 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 Label

Primary Packaging - Carton

Primary Packaging - Carton

SMILE DIRECT CLUB 
sodium fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73333-125
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Cool Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73333-125-031 in 1 CARTON09/25/2019
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 finalpart35509/25/2019
Labeler - Nutrix International, LLC (117341868)
Establishment
NameAddressID/FEIBusiness Operations
Nutrix International,LLC117341868manufacture(73333-125)

Revised: 1/2020
Document Id: 9c49660a-7546-e4e7-e053-2995a90a8548
Set id: 9c49666c-3437-47e6-e053-2a95a90ad7a5
Version: 3
Effective Time: 20200116
 
Nutrix International, LLC