NDC Code(s) : 76454-101-01
Packager : Widepipe Corp

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NATURES SMILE SODIUM FLUORIDE MOUTHWASH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76454-101
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		SODIUM FLUORIDE0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
TRICLOSAN(UNII: 4NM5039Y5X)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76454-101-01250 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 10/01/2011 10/01/2018

PRINCIPAL DISPLAY PANEL

image front and back of bottle