Active Ingredient
SODIUM FLUORIDE 0.24% (0.15% W/V FLUORIDE ION)
Luster Premium White
FDA Label NDC 72805-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by French Transit, Ltd. for the product Luster Premium White (NDC 72805-201). 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, use, warnings, otc - 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
ANTI-CAVITY
Use
HELPS PROTECT AGAINST CAVITIES.
Warnings
If you accidentally swallow more than used for brushing, get medical help,
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Directions
- Adults and children 6 years of age and older—Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by adentist or doctor.
- Children 6 to 12 years—Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 6 years—Do not use unless directed by dentist or physician.
Inactive Ingredients
Glycerin, Sorbitol, Hydrated Silica, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mica, Titanium Dioxide, Charcoal Powder, Mentha Arvensis (Cornmint) Leaf Oil, Menthol, Vanilla Planifolia Fruit Extract
Questions
1-800-823-5272 | French Transit, Ltd., Louisville, CO 80027 USA
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