Active Ingredient
Sodium Fluoride 0.925% (1445ppm w/v fluoride ion)
Tooth
FDA Label NDC 83861-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henan Dailygreen Biotechnology Co. Ltd for the product Tooth (NDC 83861-003). 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 active ingredient, purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-cavity
Use
aids in the prevention of dental cavities
Warnings
When using this product, if irritation or sensitivity occurs, discontinue use.
Otc - Do Not Use
N/A
Otc - When Using
When using this product, if irritation or sensitivity occurs, discontinue use.
Otc - Stop Use
n/a
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If more than used for brushing is accidentally swallowed, get medical help or contact a poison Control Center immediately.
Directions
• Adults and children 6 years of age and older; Chew tablet briefly and brush thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Do not swallow the tablet.
• Supervise children under 6 years of age for brushing and rinsing.
Other Information
Store at 25-30*C (68-77*F). Protect from excessive moisture.
Inactive Ingredients
Xylitol, Sodium Cocoyl Isethionate (made from coconut), Microcrystalline Cellulose, Calcium Carbonate, Sodium Bicarbonate, Erythritol, Natural Mint, Sodium Fluoride, Guar Gum
Package Label.Principal Display Panel
83861-003-01 (83861 003 01)
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