SMILEBAR WHITENING- sodium fluoride paste, dentifrice 
Smilebar

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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SMILEBAR WHITENING TOOTHPASTE WITH FLUORIDE + BAKING SODA

Drug facts

Active ingredient

Sodium Fluoride 0.243%

Purpose

Anticavity

Uses

Helps protect against cavities

Warnings: Keep out of reach of children under 6 yrs. of age.

If large amount (more than would be used for brushing) is swallowed, get medical help, or contact a Poison Control Center right away.

Directions

    meals or at least two times a day

   (or use as directed by a dentist)

Inactive ingredients:  Glycerin, Water,

Hydrated Silica, Sodium Lauryl Sulfate,

Sodium Bicarbonate, PEG, CMC, Sodium

Saccharin, Zinc Citrate, Flavor, Sucralose,

Titanium Dioxide, Tri-calcium Phosphate

Package Labeling

      WHITENING TOOTHPASTE

WITH FLUORIDE + BAKING SODA

DESIGNED FOR CLEAR ALIGNER TREATMENT

      WHITENS                 PROTECTS GUMS

FIGHTS CAVITIES      RESTORES ENAMEL

NET WT 3.4 OZ  e96 G

      WHITENS TEETH BY REMOVING

SURFACE STAINS, TARTER, AND PLAQUE               SMILEBAR.COM

Distributed by SMILEBAR

303 Columbus Ave

Boston, MA 02116

Smilebar 0.243

res

SMILEBAR WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73449-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73449-001-0196 g in 1 TUBE; Type 0: Not a Combination Product11/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/15/2019
Labeler - Smilebar (065798164)
Registrant - Smilebar (065798164)

Revised: 12/2020
Document Id: 08b95a08-5ffe-4300-8005-c66e1daaa2e4
Set id: 5c475cee-6e7e-423f-8945-de99b5458681
Version: 3
Effective Time: 20201208
 
Smilebar