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Distributed by Ultra Oral Care Inc.,
Spring, Texas, 77386
www.emmident-ultrasound.com
Emmi-dent Kids
FDA Label NDC 63956-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Emag Ag for the product Emmi-dent Kids (NDC 63956-002). 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 other, active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride 0.11% (0.06% w/v fluoride ion)
Purpose
Anticavity toothpaste
Use
helps protect against cavities
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 yrs. of age.
If more than used for dental cleaning is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
* adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist* do not swallow* to minimize swallowing use a pea-sized amount in children unter 6* supervise children's dental cleaning until good habits are established* children under 2 yrs.: ask a dentist
Inactive Ingredients
water, sorbitol, hydrated silica, propylene glycol, sodium C-14-16 olefin sulfonate, celluose gum, aroma/fragrance, titanium dioxide, sodium methylparaben, sodium saccharin
Questions?
1-833-682-8902
Principal Display Panel - 75 Ml Tube
emmi®-dent
Emmi-dent Kids
Ultrasound Toothpaste
for
Kids
Made in Germany
Made by Emag Germany
Principal Display Panel (75 mL Tube)
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