DR. WHITISS (8.3%)- carbamide peroxide gel, dentifrice

Dr. Whitiss (8.3%) by

Drug Labeling and Warnings

Dr. Whitiss (8.3%) 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

polyvinyl pyrrolidone (k=90), glycerin, anhydrous ethyl alcohol, distilled water, potassium dihydrogen phosphate, sodium hydroxide, lemon oil, orange oil, xylitol, l-menthol, potassium nitrate, propolis ext

PURPOSE

whitening of discolored vital teeth

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

apply 2 or 3 times per day for 2 weeks for a brighter, whiter smile

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 (8.3%) 
carbamide peroxide gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47649-9001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	0.083 g  in 1 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: 47649-9001-3	4 in 1 PACKAGE	07/11/2014
1	NDC: 47649-9001-2	2 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 47649-9001-1	5 g in 1 PACKAGE; Type 0: Not a Combination Product	07/11/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/11/2014

Labeler - Nibec Co., Ltd (687796909)

Registrant - Nibec Co., Ltd (687796909)

Establishment
Name	Address	ID/FEI	Business Operations
Nibec Co., Ltd		687796909	manufacture(47649-9001)