DR.WHITISS 20%- carbamide peroxide gel, dentifrice

Dr.Whitiss 20% by

Drug Labeling and Warnings

Dr.Whitiss 20% by is a Otc medication manufactured, distributed, or labeled by Nibec Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

carbamide peroxide

INACTIVE INGREDIENT

pyrrolidone (k=90), hydroxyethyl cellulose, glycerin, purified water, monobasic potassium phosphate, sodiu hydroxide, l-menthol, potassium nitrate, anhydrous ethanol

PURPOSE

whitening of discolored teeth

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the 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) do not use on patient with sensitive to carbamide peroxide
2) do not use on patient with oral infection
3) no to be used by pregnant or lactating women or children under 18 years old
4) to be used under the supervision of a dentist
5) do not swallow this medication

DOSAGE & ADMINISTRATION

for dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.WHITISS 20% 
carbamide peroxide gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47649-1201
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K90 (UNII: RDH86HJV5Z)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POTASSIUM NITRATE (UNII: RU45X2JN0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47649-1201-2	4 in 1 PACKAGE	06/07/2015
1	NDC: 47649-1201-1	1 g in 1 SYRINGE; Type 0: Not a Combination Product

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(47649-1201)