Azelex label

Azelex

Azelex Recall

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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.

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FDA Safety Alerts

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

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Manufacturer Warnings

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

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FDA Labeling Changes

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

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Uses

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

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History

There is currently no drug history available for this drug.

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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.

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Azelex Manufacturers

  • Physicians Total Care, Inc.
    Azelex | Physicians Total Care, Inc.
    No Recall

    Azelex | Physicians Total Care, Inc.

    Azelex | Physicians Total Care, Inc.

    After the skin is thoroughly washed and patted dry, a thin film of AZELEX® 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® 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.

  • Allergan, Inc.
    Azelex | Allergan, Inc.
    No Recall

    Azelex | Allergan, Inc.

    Azelex | Allergan, Inc.

    After the skin is thoroughly washed and patted dry, a thin film of AZELEX® 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® 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.

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