NDC Code(s) : 69962-014-15
Packager : Webco Dental & Medical Supplies, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FIDELIS APFSodium Fluoride GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69962-014
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 ION5.6 g in 454 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Magnesium Aluminum Silicate(UNII: 6M3P64V0NC)
Phosphoric Acid(UNII: E4GA8884NN)
Polysorbate 20(UNII: 7T1F30V5YH)
Sodium Benzoate(UNII: OJ245FE5EU)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color yellow Score
Shape Size
Flavor PINEAPPLE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69962-014-15454 g in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2014

PRINCIPAL DISPLAY PANEL

FIDELISAPFGELPINA