NDC Code(s) : 68220-141-30
Packager : Alaven Pharmaceutical LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Proctocream Hydrocortisone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68220-141
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE(UNII: WI4X0X7BPJ)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
GLYCERIN(UNII: PDC6A3C0OX)
PARAFFIN(UNII: I9O0E3H2ZE)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
LACTIC ACID(UNII: 33X04XA5AT)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68220-141-301 in 1 CARTON
130 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089414 03/18/2011

PRINCIPAL DISPLAY PANEL

principle display label