Oral Defense
FDA Label NDC 52644-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oral Defense for the product Oral Defense (NDC 52644-003). 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 drug facts, purpose, active ingredient, use, warnings, directions, question and comments?, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Cavity toothpaste
Active Ingredient
Sodium Fluoride 0.25% (0.14 w/v Fluoride Ion)
Use
Aids in prevention of dental cavities and gingivitis.
Warnings
Children under two years of age: Consult a dentist or physician. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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.
For maximum benefits, brush for 1 minute at bedtime and use with Oral Defense Fluoride Rinse.
Question And Comments?
1-800-355-9621 • 1-509-326-6693 Office
Manufactured for: Oral Defense LLC, P.O. Box 8267 Spokane, WA 99203
Patent No. US 6,861,047B
Inactive Ingredients
Sorbitol, Purified Water, Glycerin, Hydrated Silica, Sodium Lauroyl Sarconsinate, Cellulose Gum, Flavor, Titanium Dioxide, Cetylpyridinium Chloride, Citric Acid, Sodium Saccharin, FD&C Blue No. 1, Dehydroacetic Acid.
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