Capex (Fluocinolone Acetonide Topical) - Indications and Dosage

INDICATION AND USAGE

Capex^® Shampoo is a low to medium potency corticosteroid indicated for the treatment of seborrheic dermatitis of the scalp. This product has not been proven to be effective in other corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION

The pharmacist must empty the contents of the enclosed capsule into the shampoo base prior to dispensing to the patient. This product should be shaken well prior to use. No more than approximately one (1) ounce of the medicated shampoo should be applied to the scalp area once daily, worked into a lather and allowed to remain on the scalp for approximately 5 minutes. The hair and scalp should then be rinsed thoroughly with water.

HOW SUPPLIED

Capex^® Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide 0.01%, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex^® Shampoo is dispensed to the patient in a 6 ounce bottle.

NDC 0299-5500-04

Shake well before using.

Store between 15° and 30°C (59° and 86°F) in tightly closed containers.

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

Mfd. by:

Hill Laboratories, Inc.                                 20002-0700

Sanford, Florida 32773 USA              Revised: July 2000

GALDERMA is a registered trademark.