Psorcon Ointment

Name: Psorcon Ointment

psorcon Description

Each gram of psorcon Ointment contains 0.5 mg diflorasone diacetate in an ointment base. Chemically, diflorasone diacetate is 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below:

Each gram of psorcon Ointment contains 0.5 mg diflorasone diacetate in an ointment base of propylene glycol, glyceryl monostearate and white petrolatum.

Contraindications

Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

The following local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

  1. Burning
  2. Itching
  3. Irritation
  4. Dryness
  5. Folliculitis
  6. Hypertrichosis
  7. Acneiform eruptions
  8. Hypopigmentation
  9. Perioral dermatitis
  10. Allergic contact dermatitis
  11. Maceration of the skin
  12. Secondary infection
  13. Skin atrophy
  14. Striae
  15. Miliaria

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

How is psorcon Supplied

Psorcon Ointment 0.05% is available in the following size tubes:

60 gram NDC 0066-0071-60

Store at controlled room temperature, 20° to 25° C (68° to 77° F) [see USP].

Rx only

Manufactured by
Pharmacia & Upjohn Company
A Division of Pfizer Inc
Kalamazoo, MI, USA 49001
For
Dermik Laboratories, Inc.
Berwyn, PA USA 19312

50065610
813 377 212
691694
December 2001

PSORCON 
diflorasone diacetate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0066-0071
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diflorasone diacetate (diflorasone) diflorasone 0.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
propylene glycol  
glyceryl monostearate  
white petrolatum  
Packaging
# Item Code Package Description
1 NDC:0066-0071-60 60 g (60 GRAM) in 1 TUBE
Labeler - Dermik Laboratories, Inc.
Revised: 02/2006   Dermik Laboratories, Inc.
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