NDC Code(s) : 52389-649-28
Packager : Alva-Amco Pharmacal Companies, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Psoriasin Itch ControlHydrocortisone Cream CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52389-649
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE(UNII: WI4X0X7BPJ)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF POLYSACCHARIDES(UNII: W21O437517)
ALUMINUM SULFATE(UNII: 34S289N54E)
YELLOW WAX(UNII: 2ZA36H0S2V)
CALCIUM ACETATE(UNII: Y882YXF34X)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETYL ALCOHOL(UNII: 936JST6JCN)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
ICODEXTRIN(UNII: 2NX48Z0A9G)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM CETOSTEARYL SULFATE(UNII: 7ZBS06BH4B)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
VITAMIN D(UNII: 9VU1KI44GP)
TOCOPHEROL(UNII: R0ZB2556P8)
CORN OIL(UNII: 8470G57WFM)
water(UNII: 059QF0KO0R)
PETROLATUM(UNII: 4T6H12BN9U)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52389-649-281 in 1 CARTON 22/02/2016
128 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/22/2016

PRINCIPAL DISPLAY PANEL

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