Emmi Dent Sodium Fluoride Anticavity Mild
FDA Label NDC 63956-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Emag Ag for the product Emmi Dent Sodium Fluoride Anticavity Mild (NDC 63956-001). 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 emmi dent sodium fluoride anticavity toothpaste mild, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.243% (0.16 w/v fluoride ion)
Purpose
Anticavity
Use
Aids in the prevention of dental cavities.
Warnings
Otc - Keep Out Of Reach Of Children
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.
Directions
- Adults and children 2 years 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.
- Children under 2 years: Consult a dentist or doctor.
Inactive Ingredients
water, hydrated silica, sorbitol, propylene glycol, tetrapotassium pyrophosphate, xanthan, gum, sodium C14-16 olefin sulfonate, flavor, titanium dioxide, sodium methylparaben, sodium saccharin, allantoin, limonene, chamomile (chamomilla recutita) flower extract, three-lobe sage (salvia triloba) leaf extract, citral
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