SMILEBAR WHITENING- sodium fluoride paste, dentifrice

SMILEBAR Whitening by

Drug Labeling and Warnings

SMILEBAR Whitening by is a Otc medication manufactured, distributed, or labeled by Smilebar. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug facts

ACTIVE INGREDIENT

Active ingredient

Sodium Fluoride 0.243%

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Uses

Helps protect against cavities

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Directions

• Brush teeth thoroughly after

    meals or at least two times a day

   (or use as directed by a dentist)

• Do not swallow

• Not for children undre 6

INACTIVE INGREDIENT

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

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INGREDIENTS AND APPEARANCE

SMILEBAR WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73449-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73449-001-01	96 g in 1 TUBE; Type 0: Not a Combination Product	11/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/13/2019

Labeler - Smilebar (065798164)

Registrant - Smilebar (065798164)