Otc - Active Ingredient
Sodium Monofluorophosphate 0.877% (1100ppm w/v fluoride ion)
Tooth Tablet
FDA Label NDC 85346-001
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 Cosmetics Supplies Co.,ltd. for the product Tooth (NDC 85346-001). 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 otc - 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
Anticavity Toothpaste
Use
aids in the prevention of dental cavities
Warnings
Keep out of reach of children. Not to be used by children under 12 years of age.If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
Do not swallow. Do not use if seal is broken or missing. Not suitable for children under 12.
Otc - When Using
N/A
Otc - Stop Use
N/A
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Adults: Wet your toothbrush and crush the tab between your teeth. Brush like normal. Rinse after using. Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow
Directions: Bite 1 tablet and chew it into small pieces, wet your toothbrush, and brush gently. Do not swallow. Do not use if seal is broken or missing. Keep in a cool and dry place. Not suitable for children under 12.
Storage And Handling
Store at room temperature and dry place.
Inactive Ingredient
Inactive ingredients: Sorbitol, Calcium Carbonate, Probiotics, Xylitol, Magnesium Stearate, Stevia Rebaudiana Extract,Tea (Camellia Sinensis) Polyphenols, Peppermint (Mentha Piperita) Oil, Bitter Orange (Citrus Aurantium) Flower Oil, Peppermint (Mentha Piperita) Leaf Oil, Cocamidopropyl Betaine.
Package Label.Principal Display Panel
85346-001-01 (85346 001 01)
85346-001-02 (85346 001 02)
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