Dr.Whitiss 15%

Manufacturer
NIBEC Co., Ltd. | Nibec Co., Ltd
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:53:42

Label at a glance#

ProductDr.Whitiss 15%
Active ingredientCARBAMIDE PEROXIDE, SODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 15%

Sodium Fluoride 0.25%

INACTIVE INGREDIENT SECTION

Povidone (K90), Anhydrous Ethanol, Hydroxyethyl Cellulose, Glycerin, Purified Water, Monobasic Potassium Phosphate, Sodium Hydroxide, L-Menthol, Potassium Nitrate

OTC - PURPOSE SECTION

Whitening of discolored teeth

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep gel out of reach of small children.

INDICATIONS & USAGE SECTION


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 SECTION

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 SECTION

for dental use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DrWhitiss15LabelDrWhitiss15Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2265639carbamide peroxide 15 % / sodium fluoride 0.25 % Oral GelPSN1
2265639carbamide peroxide 0.15 MG/MG / sodium fluoride 0.0025 MG/MG Oral GelSCD1
2265639carbamide peroxide 0.15 MG/MG / sodium fluoride 0.0025 MG/MG Dental GelSY1
2265639carbamide peroxide 15 % / sodium fluoride 0.25 % Oral GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47649-1401-22024-07-30C16284748780-11030e365-1d9d-111a-e063-dadaa90a10e2Drug Facts
47649-1401-22024-01-30C16284748780-11030e365-1d9d-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47649-1401-1Dr.Whitiss 15%1 g in 1 SYRINGEGEL, DENTIFRICE11
47649-1401-2Dr.Whitiss 15%4 in 1 PACKAGEGEL, DENTIFRICE41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47649-1401DR.WHITISS 15% (CARBAMIDE PEROXIDE, SODIUM FLUORIDE) GEL, DENTIFRICE [NIBEC CO., LTD.]12 package rows20230203_f3ac966f-c613-3898-e053-2995a90a49c4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47649-140147649-1401-1, 47649-1401-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f3ac966f-c614-3898-e053-2995a90a49c4f3ac966f-c613-3898-e053-2995a90a49c42023-01-05WarningsExact identifier
spl id: f3ac966f-c614-3898-e053-2995a90a49c4
spl set id: f3ac966f-c613-3898-e053-2995a90a49c4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.