Westcort

Name: Westcort

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Westcort Description

Westcort® (hydrocortisone valerate ointment) Ointment, 0.2% contains hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

Chemically, hydrocortisone valerate is C26H38O6. It has the following structural formula:

Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water.

Each gram of Westcort Ointment contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer 934, dried sodium phosphate, mineral oil, propylene glycol, sodium lauryl sulfate, sorbic acid, steareth-2, steareth-100, stearyl alcohol, water, and white petrolatum.

Indications and Usage for Westcort

Westcort Ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.

Westcort Dosage and Administration

Westcort Ointment should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Westcort Ointment should not be used with occlusive dressings unless directed by a physician. Westcort Ointment should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

Package label principal display penal

15 g Tube label

15 g Carton label

Westcort 
hydrocortisone valerate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10631-105
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE VALERATE (HYDROCORTISONE) HYDROCORTISONE VALERATE 2 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC ANHYDROUS  
MINERAL OIL  
PROPYLENE GLYCOL  
SODIUM LAURYL SULFATE  
SORBIC ACID  
STEARYL ALCOHOL  
WATER  
PETROLATUM  
STEARETH-2  
STEARETH-100  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)  
Packaging
# Item Code Package Description
1 NDC:10631-105-15 15 g in 1 TUBE
2 NDC:10631-105-45 45 g in 1 TUBE
3 NDC:10631-105-60 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018726 10/06/2008
Labeler - Ranbaxy Laboratories Inc. (169932519)
Registrant - Ranbaxy Laboratories Inc. (169932519)
Establishment
Name Address ID/FEI Operations
Contract Pharmaceuticals Limited 248761249 manufacture(10631-105), pack(10631-105)
Establishment
Name Address ID/FEI Operations
Sanofi Chimie 291538267 api manufacture(10631-105)
Revised: 09/2009   Ranbaxy Laboratories Inc.
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