NDC Code(s) : 60232-8581-5, 60232-8581-2
Packager : Swiss-American Products

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Elta Dermavase Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60232-8581
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide75 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Propylene Glycol(UNII: 6DC9Q167V3)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
Sodium Hydroxide(UNII: 55X04QC32I)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Disodium EDTA-copper(UNII: 6V475AX06U)
Sodium Chloride(UNII: 451W47IQ8X)
Sodium Bisulfite(UNII: TZX5469Z6I)
Papain(UNII: A236A06Y32)
BROMELAINS(UNII: U182GP2CF3)
Dimethicone(UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
Isopropyl Palmitate(UNII: 8CRQ2TH63M)
petrolatum(UNII: 4T6H12BN9U)
Hexyl Laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
Hydrogenated Castor Oil(UNII: ZF94AP8MEY)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
ORANGE OIL(UNII: AKN3KSD11B)
Ergocalciferol(UNII: VS041H42XC)
FIG(UNII: TGD87RII2U)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
Polyglyceryl-4 Isostearate(UNII: 820DPX33S7)
Butylene Glycol(UNII: 3XUS85K0RA)
Phenoxyethanol(UNII: HIE492ZZ3T)
Biotin(UNII: 6SO6U10H04)
Amino Acids(UNII: 0O72R8RF8A)
Glutamine(UNII: 0RH81L854J)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
Proline(UNII: 9DLQ4CIU6V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60232-8581-5142 g in 1 TUBE
2NDC:60232-8581-259 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/30/2009

PRINCIPAL DISPLAY PANEL

Image of 2oz Tube