Azelex (Azelaic acid) (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid.

Structural Formula: HOOC-(CH)-COOH

Chemical Name: 1,7-heptanedicarboxylic acid

Empirical Formula: CHO

Molecular Weight: 188.22

The exact mechanism of action of azelaic acid is not known. The following data are available, but their clinical significance is unknown. Azelaic acid has been shown to possess antimicrobial activity against The antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis.

A normalization of keratinization leading to an anticomedonal effect of azelaic acid may also contribute to its clinical activity. Electron microscopic and immunohistochemical evaluation of skin biopsies from human subjects treated with Azelex (Azelaic acid) Cream demonstrated a reduction in the thickness of the stratum corneum, a reduction in number and size of keratohyalin granules, and a reduction in the amount and distribution of filaggrin (a protein component of keratohyalin) in epidermal layers. This is suggestive of the ability to decrease microcomedo formation.

Azelex (Azelaic acid) Cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

Azelex (Azelaic acid) Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Azelex (Azelaic acid) Cream is for dermatologic use only and not for ophthalmic use.

There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexions, these patients should be monitored for early signs of hypopigmentation.

During U.S. clinical trials with Azelex (Azelaic acid) Cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of Azelex (Azelaic acid) Cream.

In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.

After the skin is thoroughly washed and patted dry, a thin film of Azelex (Azelaic acid) Cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of Azelex (Azelaic acid) Cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.

Azelex (Azelaic acid) Cream is supplied in a closed orifice tube with a white, spiked screwcap in the following sizes:

30 g - NDC 0023-8694-3050 g - NDC 0023-8694-50

Store between 15° - 30° C (59° - 86° F).

Distributed by:

Irvine, California 92612, U.S.A.

©2004 Allergan, Inc.

Made in Italy

8466X

Distributed under license.

Revised May 2004

70896US15P