ZITHRANOL-RR (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Generally, it is recommended that Zithranol-RR cream be applied once a day. Anthralin is known to be a potential skin irritant. The irritant potential of anthralin is directly related to the strength being used, the time of contact, and each patient’s individual tolerance. Where the response to anthralin treatment has not previously been established, commence treatment using a short contact time (5 – 15 min.) for at least one week. When a short contact time is used initially, it can be increased stepwise to thirty minutes before removing the cream by washing or showering. The optimal period of contact will vary according to the patient’s response to treatment.

For the skin: Apply sparingly to the psoriatic lesions avoiding normal skin and rub gently and carefully into the skin. Avoid applying an excessive quantity which may cause unnecessary soiling and staining of the clothing and/or bed linen. At the end of each period of treatment, rinse the skin thoroughly with cool to lukewarm water before washing with soap. The margins of the lesions may gradually become stained purple/brown as treatment progresses, but this will disappear after cessation of treatment.

For the scalp: Wash the hair with shampoo, rinse with water and apply Zithranol-RR cream while the hair is still damp. Rub the cream well into the psoriatic lesions. Keep Zithranol-RR cream away from the eyes. Care should be taken to avoid application to uninvolved scalp margins. Remove any unintended residue which may be deposited behind the ears. At the end of each period of contact, rinse hair and scalp thoroughly with cool to lukewarm water and then shampoo the hair and scalp to remove any surplus cream. This treatment may be repeated on alternate days if necessary.

HOW SUPPLIED

Zithranol-RR (anthralin) microcrystalline encapsulated cream, 1.2% is supplied in tubes.

45g NDC 42783-101-45
15g NDC 42783-101-15

Store at controlled room temperature 59°F to 86°F (15°C to 30°C).

Manufactured for:
Elorac, Inc. Vernon Hills, IL 60061

U.S. Patent Pending

Caution: Federal law prohibits dispensing without prescription.

07/2008

ZITHRANOL-RR anthralin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42783-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
anthralin (anthralin) anthralin .012 g in 1 g
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid
Product Characteristics
Color green Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42783-101-45 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (42783-101-45)
2 NDC:42783-101-15 6 TUBE (TUBE) in 1 CARTON contains a TUBE
2 15 g in 1 TUBE This package is contained within the CARTON (42783-101-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/09/2009
Labeler — Elorac Inc. (832590009)
Registrant — Elorac Inc. (832590009)
Establishment
Name Address ID/FEI Operations
Harmony 784625760 manufacture

Revised: 01/2010 Elorac Inc.

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