NDC Code(s) : 68400-207-04
Packager : Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Gelato Homecare Vivid NeutralSodium Fluoride GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-207
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 ION0.597 g in 120 g
Inactive Ingredients
Ingredient Name Strength
CASEIN(UNII: 48268V50D5)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GLYCERIN(UNII: PDC6A3C0OX)
DMDM HYDANTOIN(UNII: BYR0546TOW)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM POLYMETAPHOSPHATE(UNII: P1BM4ZH95L)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TRICALCIUM PHOSPHATE(UNII: K4C08XP666)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
XYLITOL(UNII: VCQ006KQ1E)
Product Characteristics
Color white Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68400-207-04120 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/15/2013

PRINCIPAL DISPLAY PANEL

VividCherryLBL

PRINCIPAL DISPLAY PANEL

VividBox