Otc - Active Ingredient
Carbamide Peroxide 15%
Sodium Fluoride 0.25%
Dr.whitiss 15%
FDA Label NDC 47649-1401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nibec Co., Ltd. for the product Dr.whitiss 15% (NDC 47649-1401). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Povidone (K90), Anhydrous Ethanol, Hydroxyethyl Cellulose, Glycerin, Purified Water, Monobasic Potassium Phosphate, Sodium Hydroxide, L-Menthol, Potassium Nitrate
Otc - Purpose
Whitening of discolored teeth
Otc - Keep Out Of Reach Of Children
Keep gel out of reach of small children.
Indications & Usage
1. Gingival and general oral heath should be confirmed before treatment.
2. Brush your teeth before treatment.
3. Follow your dentist’s instructions on how to load gel into your custom whitening tray. Use no more than 1/3 to 1/2 of the syringe per tray.
4. Insert whitening tray in the mouth over the teeth. Seat the tray firmly agains the teeth. Remove excess gel with clean finger or soft toothbrush.(Rinse twice; do not swallow rinsed gel.)
5. Unless directed otherwise by your dentist, wear Dr.Whitiss 10% for 8-10 hours or overnight, Dr.Whitiss 15% for 4-6 hours, Dr.Whitiss20% for 2-4 hours, and Dr.Whitiss 35% for 30 minutes.
6. If significant sensitivity occurs, stop treatment and consult dentist.
Warnings
1. Products containing peroxides are not recommended for children under the age of 18 and pregnant or lactating women.
2. Regular dental checkups and cleanings are important before and after bleaching to maintain a healthy smile.
3. Do not use this product if you are allergic to any of the ingredients.
4. If you have any questions regarding the appropriate use of this product, including how long it will take to bleach your teeth, please consult a dentist as soon as possible.
5. If irritation occurs such as redness, soreness, or swelling of the gums or mouth, discontinue use and consult a dental professional or physician.
6. Do not swallow. If a significant amount is swallowed, please call Poison Control immediately.
7. Do not use tobacco, and other products can restain your teeth over time. Should this occur, the teeth can be rewhitened within a few nights using gel.
8. Crowns, bridges, partial dentures, veneers, and composite fillings will not bleach.
9. Keep gel out of reach of small children.
10. Store bleach out of the sun and heat. Refrigeration recommended. Do not freeze.
Dosage & Administration
for dental use only
Package Label.Principal Display Panel
Drwhitiss15label (Drwhitiss15label)
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