DR.WHITISS 15%- carbamide peroxide, sodium fluoride gel, dentifrice

Dr.Whitiss 15% by

Drug Labeling and Warnings

Dr.Whitiss 15% by is a Otc medication manufactured, distributed, or labeled by NIBEC Co., Ltd., Nibec Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Carbamide Peroxide 15%

Sodium Fluoride 0.25%

INACTIVE INGREDIENT

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

PURPOSE

Whitening of discolored teeth

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.WHITISS 15% 
carbamide peroxide, sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47649-1401
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	150 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K90 (UNII: RDH86HJV5Z)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POTASSIUM NITRATE (UNII: RU45X2JN0Z)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
LEVOMENTHOL (UNII: BZ1R15MTK7)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47649-1401-2	4 in 1 PACKAGE	06/07/2015
1	NDC: 47649-1401-1	1 g in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/07/2015

Labeler - NIBEC Co., Ltd. (687796909)

Registrant - NIBEC Co., Ltd. (687796909)

Establishment
Name	Address	ID/FEI	Business Operations
Nibec Co., Ltd		687796909	manufacture(47649-1401) , label(47649-1401) , pack(47649-1401)