A prescription acne product1
AZELEX (azelaic acid cream) 20%
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AZELEX is a topical 20% azelaic acid cream used to treat mild-to-moderate inflammatory acne.1

AZELEX (azelaic acid cream) 20% product packaging

AZELEX is available in a topical 20% azelaic acid cream to prescribe for your appropriate patients, ages 12 years and older. AZELEX is formulated for application to the skin and is applied twice daily.

AZELEX provides a well-established topical treatment option when evaluating patients who may benefit from prescription treatment.

Please click here for the full Prescribing Information.

Reference:

1. AZELEX® Prescribing Information. Almirall, LLC.

INDICATIONS AND USAGE

AZELEX® (azelaic acid cream) 20% cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

AZELEX cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS AND PRECAUTIONS

  • AZELEX cream is for dermatologic use only and not for ophthalmic use.
  • Hypopigmentation: 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.
  • If sensitivity or severe irritation develops with the use of AZELEX cream, treatment should be discontinued and appropriate therapy instituted.

ADVERSE REACTIONS

The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling.

USE IN SPECIFIC POPULATIONS

Pregnancy: No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women. AZELEX cream should be used during pregnancy only if clearly needed.

Nursing Mothers: The uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when AZELEX cream is administered to a nursing mother.

Pediatric Use: Safety and effectiveness in pediatric patients under 12 years of age have not been established.

Please see full Prescribing Information.