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Smilebar Whitening
FDA Label NDC 73449-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smilebar for the product Smilebar Whitening (NDC 73449-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Sodium Fluoride 0.243%
Otc - 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.
Otc - Keep Out Of Reach Of Children
Dosage & Administration
Directions
- Brush teeth thoroughly after
- Do not swallow
- Not for children undre 6
meals or at least two times a day
(or use as directed by a dentist)
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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