NDC Code(s) : 69962-022-12
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 AEROSOL, FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69962-022
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 ION1.5375 g in 125 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
HYDROFLUORIC ACID(UNII: RGL5YE86CZ)
PHOSPHORIC ACID(UNII: E4GA8884NN)
POLOXAMER 407(UNII: TUF2IVW3M2)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM LAURETH-3 SULFATE(UNII: BPV390UAP0)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TROLAMINE(UNII: 9O3K93S3TK)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color white Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69962-022-12125 g in 1 BOTTLE, PUMP 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

FIDELISAPFFOAMMNT