NDC 59779-814-58
API & Excipient Details

marketed by CVS Pharmacy under NDC Code 59779-814-58

NDC Code(s) : 59779-814-57, 59779-814-58
Packager : CVS Pharmacy

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sensitive Whitening Fluoride and Potassium Nitrate GEL

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:59779-814
Route of Administration	DENTAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM NITRATE(UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5.0 g in 100 g
SODIUM FLUORIDE(UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL(UNII: 506T60A25R)	31.3009 g in 100 g
WATER(UNII: 059QF0KO0R)	29.3548 g in 100 g
SACCHARIN SODIUM DIHYDRATE(UNII: SB8ZUX40TY)	0.2 g in 100 g
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)	1.5 g in 100 g
SODIUM HYDROXIDE(UNII: 55X04QC32I)	0.001 g in 100 g
FD&C BLUE NO. 1(UNII: H3R47K3TBD)	0.0003 g in 100 g
GLYCERIN(UNII: PDC6A3C0OX)	8.5 g in 100 g
XANTHAN GUM(UNII: TTV12P4NEE)	0.6 g in 100 g
CHONDRUS CRISPUS(UNII: OQS23HUA1X)	0.8 g in 100 g
HYDRATED SILICA(UNII: Y6O7T4G8P9)	20.5 g in 100 g
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)	0.4 g in 100 g
SODIUM METHYL COCOYL TAURATE(UNII: JVL98CG53G)	0.8 g in 100 g
ISOPENTANE(UNII: ZH67814I0O)

Product Characteristics
Color	blue (BLUE AND GREEN)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-814-58	12 in 1 CASE
1	NDC:59779-814-57	121.6 g in 1 CAN

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	12/13/2011

PRINCIPAL DISPLAY PANEL