Dr.Whitiss 15%

Manufacturer
NIBEC Co., Ltd. | Nibec Co., Ltd
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:01:56

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47649-1102-22023-01-30C16284748780-1f386c64a-13f6-0266-e053-dadaa90a7c1aDrug Facts

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47649-110247649-1102-1, 47649-1102-2

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#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9968aa66-9eed-1b39-e053-2995a90a1ecc99689ede-29bb-17cb-e053-2995a90a53282019-12-09WarningsExact identifier
spl id: 9968aa66-9eed-1b39-e053-2995a90a1ecc
spl set id: 99689ede-29bb-17cb-e053-2995a90a5328

Reported adverse events (FAERS/openFDA)#

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