Active Ingredient
Sodium Fluoride 0.24%
Smile Direct Club
FDA Label NDC 73333-125
8 label sections · Submitted to the FDA by Nutrix, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nutrix, Llc for the product Smile Direct Club (NDC 73333-125). 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 active ingredient, purpose, indications and usage section, warnings, keep out of reach of children, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
