Active Ingredient
Sodium Fluoride 1.54mg (0.7mg fluoride ion)
Tooth
FDA Label NDC 83861-002
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 83861-002). 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
- Use this product only for brushing your teeth.
- Do not swallow the toothpaste tablets.
- Keep out of reach of children.
- Small tablets may be a choking hazard for children under 3 years old.
- Keep toothpaste away from pets.
- If you experience any irritation or sensitivity while using this product, discontinue use.
Otc - Do Not Use
N/A
Otc - When Using
n/a
Otc - Stop Use
If you experience any irritation or sensitivity while using this product, discontinue use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- Adults and children 6 years of age and older: Chew 1 tablet until crushed.
- Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.
- Spit out: Do not swallow the tablet.
- Children under 6 years of age should be supervised when using this product.
Other Information
Store at 1-30 °℃ (33.8 - 86°F).
Protect from excessive moisture.
Inactive Ingredients
Silica, Tetrasodium pyrophosphate, Pyridoxine HCI (Vitamin B6), Sorbitol, Microcrystalline cellulose, Xylitol, Stevia rebaudiana extract, Sodium chloride, Hydroxypropyi cellulose, Xanthan gum, Sodium cocoyl glutamate, Sodium bicarbonate, Magnesium stearate, Hydroxyapatite, Tocopheryl acetate (Vitamin E), Sodium ascorbate (Vitamin C), Menthol, Flavor, Camellia sinensis leaf extract, Eucalyptus globulus leaf oil, Rosmarinus officinalis (Rosemary) leaf extract
Package Label.Principal Display Panel
83861-002-01 (83861 002 01)
83861-002-02 (83861 002 02)
83861-002-03 (83861 002 03)
83861-002-04 (83861 002 04)
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