NDC Code(s) : 49738-178-82, 49738-178-89
Packager : Kmart Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kmart Corporation Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49738-178
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STANNOUS FLUORIDE(UNII: 3FTR44B32Q)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.4540 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ZINC LACTATE(UNII: 2GXR25858Y)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 600(UNII: NL4J9F21N9)
SODIUM PHOSPHATE, TRIBASIC(UNII: A752Q30A6X)
SODIUM TRIPOLYPHOSPHATE(UNII: 5HK03SA80J)
SODIUM GLUCONATE(UNII: R6Q3791S76)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
XANTHAN GUM(UNII: TTV12P4NEE)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM PHOSPHATE(UNII: SE337SVY37)
CHONDRUS CRISPUS(UNII: OQS23HUA1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49738-178-891 in 1 CARTON
1NDC:49738-178-82170 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 12/01/2012

PRINCIPAL DISPLAY PANEL

mm1.jpg

Carton label

mm2.jpg

Carton label