Pro Care Flouride
FDA Label NDC 78989-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Diligo Holdings Joint Stock Company for the product Pro Care Flouride (NDC 78989-001). 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 drugs facts:, active ingredient, purpose, use, keep out of reach of children under 6 years of age., other information, inactive ingredients, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.21%
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Keep Out Of Reach Of Children Under 6 Years Of Age.
If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
Other Information
Use at least 0.04 oz (1 g) of toothpaste. Close the cap after usage. Keep away from direct sunlight for a long time.
Inactive Ingredients
Cellulose Gum, Hydrate Silica, Flavor, Mica, Organic psidium guajava fruit, PEG-32, Propolis Extract, Sodium Chloride, Sodium Lauryl Sulfate, Sodium Sarcharin, Sorbitol, Troxerutin, Water, Xylitol.
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 dentis or doctor.
Children under 6 years old of age. Intruct in good brushing and rinsing habits ( to minimize swallowing) Supevise children as necessary until capable of using without supervison.
Children under 2 years old of age. Consult a dentist or doctor.
Package Labeling:
Bottle (Bottle)
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