NDC Code(s) : 59088-746-08
Packager : PureTek Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GenRx Daily Defense AntifungalMiconazole Nitrate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-746
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE(UNII: VW4H1CYW1K)
(MICONAZOLE - UNII:7NNO0D7S5M) 		MICONAZOLE NITRATE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
KUKUI NUT OIL(UNII: TP11QR7B8R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
SAFFLOWER OIL(UNII: 65UEH262IS)
CETYL ALCOHOL(UNII: 936JST6JCN)
CETYL PHOSPHATE(UNII: VT07D6X67O)
CHLORPHENESIN(UNII: I670DAL4SZ)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER(UNII: RSA9I561OK)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
LEVOMENOL(UNII: 24WE03BX2T)
CALCIUM PANTOTHENATE(UNII: 568ET80C3D)
CARTHAMUS TINCTORIUS SEED OLEOSOMES(UNII: 9S60Q72309)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
NIACINAMIDE(UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
GINGER(UNII: C5529G5JPQ)
PEG-100 STEARATE(UNII: YD01N1999R)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
WATER(UNII: 059QF0KO0R)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59088-746-08118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 01/08/2013

PRINCIPAL DISPLAY PANEL

GenRx Daily Defense Antifungal Cream 4 oz image