Otc - Active Ingredient
Active Ingredient Purpose
Sodium monofluorophosphate 0.76%---------------------------------------------------- Anticavity
(Total Fluoride Content - 1000 ppm Approx.)
Idodent Flouride Mint
FDA Label NDC 65923-181
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Idodent Flouride Mint (NDC 65923-181). 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, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Regular brushing with fluoride toothpaste helps protect teeth and roots against cavities
Warnings
Warnings
Otc - Keep Out Of Reach Of Children
Warnings
Keep out of reach of children under 6 years of age.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Indications & Usage
Directions
| Adults and children 2 years and older | Brush Teeth thoroughly after meals, twice a day, or use as directed by a dentist or physician. |
| Children under 6 years | To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established. |
| Children under 2 years | Ask a dentist or physician. |
Storage And Handling
Other Information
Store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, flavor, cellulose gum, sodium silicate, tetrasodium, propphosphate, sodium saccharin, titanium dioxide, methylparaben, PEG-8, propylparaben
Dosage & Administration
Distributed by:
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703 USA
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