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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE(UNII: RU45X2JN0Z)
(NITRATE ION - UNII:T93E9Y2844) 		POTASSIUM NITRATE5.0 g in 100 g
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		SODIUM FLUORIDE0.15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59779-814-5812 in 1 CASE
1NDC:59779-814-57121.6 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 12/13/2011

PRINCIPAL DISPLAY PANEL

image of can label