OTC - ACTIVE INGREDIENT SECTION
Carbamide Peroxide 15%
Sodium Fluoride 0.25%
Carbamide Peroxide 15%
Sodium Fluoride 0.25%
Povidone (K90), Anhydrous Ethanol, Hydroxyethyl Cellulose, Glycerin, Purified Water, Monobasic Potassium Phosphate, Sodium Hydroxide, L-Menthol, Potassium Nitrate
Whitening of discolored teeth
Keep gel out of reach of small children.
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.
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.
for dental use only
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2265639 | carbamide peroxide 15 % / sodium fluoride 0.25 % Oral Gel | PSN | 1 |
| 2265639 | carbamide peroxide 0.15 MG/MG / sodium fluoride 0.0025 MG/MG Oral Gel | SCD | 1 |
| 2265639 | carbamide peroxide 0.15 MG/MG / sodium fluoride 0.0025 MG/MG Dental Gel | SY | 1 |
| 2265639 | carbamide peroxide 15 % / sodium fluoride 0.25 % Oral Gel | SY | 1 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 47649-1401-2 | 2024-07-30 | C162847 | 48780-1 | 1030e365-1d9d-111a-e063-dadaa90a10e2 | Drug Facts |
| 47649-1401-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1d9d-111a-e063-dadaa90a10e2 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47649-1401-1 | Dr.Whitiss 15% | 1 g in 1 SYRINGE | GEL, DENTIFRICE | 1 | 1 | |
| 47649-1401-2 | Dr.Whitiss 15% | 4 in 1 PACKAGE | GEL, DENTIFRICE | 4 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 47649-1401 | DR.WHITISS 15% (CARBAMIDE PEROXIDE, SODIUM FLUORIDE) GEL, DENTIFRICE [NIBEC CO., LTD.] | 1 | 2 package rows | 20230203_f3ac966f-c613-3898-e053-2995a90a49c4.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 47649-1401 | 47649-1401-1, 47649-1401-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE K90 | RDH86HJV5Z | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| POTASSIUM NITRATE | RU45X2JN0Z | IACT |
| POTASSIUM PHOSPHATE, MONOBASIC | 4J9FJ0HL51 | IACT |
| LEVOMENTHOL | BZ1R15MTK7 | IACT |
| HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) | S38J6RZN16 | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f3ac966f-c614-3898-e053-2995a90a49c4 | f3ac966f-c613-3898-e053-2995a90a49c4 | 2023-01-05 | Warnings | f3ac966f-c614-3898-e053-2995a90a49c4 f3ac966f-c613-3898-e053-2995a90a49c4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.