NDC Code(s) : 64854-016-01, 0-7502004871-4
Packager : Discus Dental, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluoridex Daily Defense Clean Mint 5000ppm1.1% Sodium Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64854-016
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION.011 1 in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MINT(UNII: FV98Z8GITP)
GLYCERIN(UNII: PDC6A3C0OX)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLOXAMER 234(UNII: 66EV99AS9E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color green Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0-7502004871-41 in 1 PACKAGE
1NDC:64854-016-01112 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/27/2013

PRINCIPAL DISPLAY PANEL

Outer Carton