NDC Code(s) : 41190-207-72, 41190-207-79
Packager : Wakefern

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Wakefern Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41190-207
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 ION0.24 g in 100 g
POTASSIUM NITRATE(UNII: RU45X2JN0Z)
(NITRATE ION - UNII:T93E9Y2844) 		POTASSIUM NITRATE5.0 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM TRIPOLYPHOSPHATE(UNII: 5HK03SA80J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBITOL(UNII: 506T60A25R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
GLYCERIN(UNII: PDC6A3C0OX)
XANTHAN GUM(UNII: TTV12P4NEE)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
SODIUM METHYL COCOYL TAURATE(UNII: JVL98CG53G)
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41190-207-791 in 1 CARTON
1NDC:41190-207-72113 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/03/2013

PRINCIPAL DISPLAY PANEL

mm1.jpg

Carton label

mm2.jpg

Carton label