NDC Code(s) : 10631-105-15, 10631-105-45, 10631-105-60
Packager : Ranbaxy Laboratories Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

WestcortHydrocortisone valerate OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10631-105
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE VALERATE(UNII: 68717P8FUZ)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE VALERATE2 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC ANHYDROUS(UNII: 22ADO53M6F)
MINERAL OIL(UNII: T5L8T28FGP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBIC ACID(UNII: X045WJ989B)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
WATER(UNII: 059QF0KO0R)
PETROLATUM(UNII: 4T6H12BN9U)
STEARETH-2(UNII: V56DFE46J5)
STEARETH-100(UNII: 4OH5W9UM87)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(UNII: Z135WT9208)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10631-105-1515 g in 1 TUBE
2NDC:10631-105-4545 g in 1 TUBE
3NDC:10631-105-6060 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018726 10/06/2008

PRINCIPAL DISPLAY PANEL

ID="inv-d8eec4e8-0ab7-4ace-8ed9-d617b3b41b5f"> 15gtube15 g Tube label 15gtube15 g Carton label