Azelex

Azelex

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Questions & Answers

Side Effects & Adverse Reactions

AZELEX® 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

AZELEX® Cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

History

There is currently no drug history available for this drug.

Other Information

AZELEX® (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid.

Structural Formula: HOOC-(CH2)7-COOH

Chemical Name: 1,7-heptanedicarboxylic acid

Empirical Formula: C9H16O4

Molecular Weight: 188.22

Active Ingredient: Each gram of AZELEX® contains azelaic acid......... 0.2 gm (20% w/w).

Inactive Ingredients: cetearyl octanoate; glycerin; glyceryl stearate and cetearyl alcohol and cetyl palmitate and cocoglycerides; PEG-5 glyceryl stearate; propylene glycol; and purified water. Benzoic acid is present as a preservative.

Azelex Manufacturers


  • Physicians Total Care, Inc.
    Azelex (Azelaic Acid) Cream [Physicians Total Care, Inc.]
  • Allergan, Inc.
    Azelex (Azelaic Acid) Cream [Allergan, Inc.]

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