Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED AZELEX ® cream is supplied in a closed orifice tube with a white, spiked screwcap in the following sizes: 30 g - NDC 16110-869-30 50 g - NDC 16110-869-50 Storage: Protect from freezing. Store product on its side. Store at 15°-30° C (59°-86° F). Revised: 02/2024 Distributed by Almirall, LLC, Malvern, PA 19355, U.S.A. © 2019 Almirall. All right reserved. ® marks owned by Almirall, LLC. Made in Italy by LEO Pharma Manufacturing Italy S.r.l., Segrate (Milan), Italy; PRINCIPAL DISPLAY PANEL - NDC: 16110-869-30 - 30 gram Carton Label 30 gram Carton Label; PRINCIPAL DISPLAY PANEL - NDC: 16110-869-50 - 50 gram Carton Label 50 gram Carton Label; PRINCIPAL DISPLAY PANEL - NDC: 16110-869-30 - 30 gram Tube Label 30 gram Tube Label; PRINCIPAL DISPLAY PANEL - NDC: 16110-869-50 - 50 gram Tube Label 50 gram Tube Label
- HOW SUPPLIED AZELEX ® cream is supplied in a closed orifice tube with a white, spiked screwcap in the following sizes: 30 g - NDC 16110-869-30 50 g - NDC 16110-869-50 Storage: Protect from freezing. Store product on its side. Store at 15°-30° C (59°-86° F). Revised: 02/2024 Distributed by Almirall, LLC, Malvern, PA 19355, U.S.A. © 2019 Almirall. All right reserved. ® marks owned by Almirall, LLC. Made in Italy by LEO Pharma Manufacturing Italy S.r.l., Segrate (Milan), Italy
- PRINCIPAL DISPLAY PANEL - NDC: 16110-869-30 - 30 gram Carton Label 30 gram Carton Label
- PRINCIPAL DISPLAY PANEL - NDC: 16110-869-50 - 50 gram Carton Label 50 gram Carton Label
- PRINCIPAL DISPLAY PANEL - NDC: 16110-869-30 - 30 gram Tube Label 30 gram Tube Label
- PRINCIPAL DISPLAY PANEL - NDC: 16110-869-50 - 50 gram Tube Label 50 gram Tube Label
Overview
AZELEX ® (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Structural Formula: HOOC-(CH 2 ) 7 -COOH Chemical Name: 1,7-heptanedicarboxylic acid Empirical Formula: C 9 H 16 O 4 Molecular Weight: 188.22 Active Ingredient: Each gram of AZELEX ® contains azelaic acid......... 0.2 g (20% w/w). Inactive Ingredients: cetearyl octanoate; cetostearyl alcohol; glycerin; glyceryl mono and dipalmitostearate; glyceryl monostearate; isopropyl myristate; PEG-30 stearate; propylene glycol; and purified water. Benzoic acid is present as a preservative.
Indications & Usage
AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS 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.
Contraindications
AZELEX ® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
Adverse Reactions
During U.S. clinical trials with AZELEX ® 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 ® 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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.