NDC Code(s) : 60232-8577-2, 60232-8577-5
Packager : Swiss-American Products

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Elta Trivase Miconazole Nitrate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60232-8577
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 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Sodium Hydroxide(UNII: 55X04QC32I)
Citric Acid(UNII: 2968PHW8QP)
Allantoin(UNII: 344S277G0Z)
DISODIUM EDTA-COPPER(UNII: 6V475AX06U)
Propylene Glycol(UNII: 6DC9Q167V3)
SODIUM BISULFATE(UNII: BU8V88OWIQ)
Papain(UNII: A236A06Y32)
BROMELAINS(UNII: U182GP2CF3)
Petrolatum(UNII: 4T6H12BN9U)
Dimethicone(UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
Propylparaben(UNII: Z8IX2SC1OH)
YELLOW WAX(UNII: 2ZA36H0S2V)
Hydrogenated Castor Oil(UNII: ZF94AP8MEY)
Zinc Oxide(UNII: SOI2LOH54Z)
Isopropyl Palmitate(UNII: 8CRQ2TH63M)
ORANGE OIL(UNII: AKN3KSD11B)
FIG(UNII: TGD87RII2U)
Biotin(UNII: 6SO6U10H04)
Amino Acids(UNII: 0O72R8RF8A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60232-8577-259 g in 1 TUBE
2NDC:60232-8577-5148 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333C 04/30/2002

PRINCIPAL DISPLAY PANEL

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