NDC Code(s) : 0234-8200-04
Packager : Molnlycke Health Care

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PreviSense Moisture Barrier CreamDimethicone 5% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0234-8200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM(UNII: 4T6H12BN9U)
METHYLPARABEN(UNII: A2I8C7HI9T)
ZINC OXIDE(UNII: SOI2LOH54Z)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
YELLOW WAX(UNII: 2ZA36H0S2V)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
CETYL DIMETHICONE 25(UNII: U4AS1BW4ZB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0234-8200-04118 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 part347 04/01/2016

PRINCIPAL DISPLAY PANEL

PreviSense Moisture Barrier Cream 4 oz