NDC Code(s) : 60232-8200-4
Packager : Swiss American Products

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Elta SealZinc Oxide Skin Protectant CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60232-8200
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 OXIDE60 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PETROLATUM(UNII: 4T6H12BN9U)
DIMETHICONE 1000(UNII: MCU2324216)
CETYL DIMETHICONE 25(UNII: U4AS1BW4ZB)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
YELLOW WAX(UNII: 2ZA36H0S2V)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60232-8200-4114 g in 1 TUBE 01/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 12/01/2012

PRINCIPAL DISPLAY PANEL

Elta Seal Artwork