NDC Code(s) : 0234-8578-02
Packager : Molnlycke Health Care

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PreviSense Antifungal Moisture Barrier with Protease TechnologyMiconazole Nitrate 2.0% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0234-8578
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE(UNII: VW4H1CYW1K)
(MICONAZOLE - UNII:7NNO0D7S5M) 		MICONAZOLE NITRATE2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
KIWI FRUIT(UNII: 71ES77LGJC)
FIG(UNII: TGD87RII2U)
YELLOW WAX(UNII: 2ZA36H0S2V)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ERGOCALCIFEROL(UNII: VS041H42XC)
GLUTAMINE(UNII: 0RH81L854J)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROLINE(UNII: 9DLQ4CIU6V)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
BIOTIN(UNII: 6SO6U10H04)
BROMELAINS(UNII: U182GP2CF3)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
PETROLATUM(UNII: 4T6H12BN9U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM BISULFITE(UNII: TZX5469Z6I)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ZINC OXIDE(UNII: SOI2LOH54Z)
CETYL DIMETHICONE 25(UNII: U4AS1BW4ZB)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)(UNII: L605B5892V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0234-8578-0259 g in 1 TUBE Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 04/01/2016

PRINCIPAL DISPLAY PANEL

PreviSense Antifungal Moisture Barrier 2 oz