Azelaic Acid

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of azelaic acid gel.
• Apply and gently massage a thin layer of azelaic acid gel into the affected areas on the face twice daily (morning and evening).
• Wash hands immediately following application of azelaic acid gel.
• Cosmetics may be applied after the application of azelaic acid gel has dried.
• Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy.
• Avoid the use of occlusive dressings or wrappings.
• Instruct patients to
• avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
• For topical use.
• Not for oral, ophthalmic or intravaginal use.
• Apply a thin layer twice daily to affected area(s).
• ( 2 ) Use only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before applying azelaic acid gel.
• ( 2 ) Wash hands immediately following application.
• ( 2 ) Cosmetics may be applied after the application of azelaic acid gel has dried.
• ( 2 )
• Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
• ( 2 ) For topical use.
• ( 2 ) Not for oral, ophthalmic or intravaginal use.
• ( 2 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

The safety and effectiveness of azelaic acid gel have not been established in pediatric patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of azelaic acid gel did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%).
• ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily azelaic acid gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks.
• In all three trials, the most common treatment-related adverse events were:
• burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%).
• In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for azelaic acid gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks.
• Table 1:
• Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event.
• Azelaic Acid Gel, 15% N=457 (100%) Vehicle N=331 (100%) Mild N=99 (22%) Moderate N=61 (13%) Severe N=27 (6%) Mild N=46 (14%) Moderate N=30 (9%) Severe N=5 (2%) Burning/stinging/tingling 71 (16%) 42 (9%) 17 (4%) 8 (2%) 6 (2%) 2 (1%) Pruritus 29 (6%) 18 (4%) 5 (1%) 9 (3%) 6 (2%) 0 (0%) Scaling/dry skin/xerosis 21 (5%) 10 (2%) 5 (1%) 31 (9%) 14 (4%) 1 (<1%) Erythema/irritation 6 (1%) 7 (2%) 2 (<1%) 8 (2%) 4 (1%) 2 (1%) Contact dermatitis 2 (<1%) 3 (1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%) Edema 3 (1%) 2 (<1%) 0 (0%) 3 (1%) 0 (0%) 0 (0%) Acne 3 (1%) 1 (<1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%) In patients using azelaic acid formulations, the following adverse events have been reported:
• worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis.
• Local Tolerability Studies Azelaic acid gel and its vehicle caused irritant reactions at the application site in human dermal safety studies.
• Azelaic acid gel caused significantly more irritation than its vehicle in a cumulative irritation study.
• Some improvement in irritation was demonstrated over the course of the clinical trials, but this improvement might be attributed to subject dropouts.
• No phototoxicity or photoallergenicity were reported in human dermal safety studies.
• 6.2 Postmarketing Experience The following adverse reactions have been identified post approval of azelaic acid gel.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure:
• Eyes:
• iridocyclitis upon accidental exposure of the eyes to azelaic acid gel.
• Hypersensitivity: angioedema, eye swelling, facial swelling, urticaria.
• Respiratory: worsening of asthma, dyspnea, wheezing.
• Skin reactions: application site rash.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Inform patients using azelaic acid gel of the following:
• Administration Instructions For topical use only.
• Before applying azelaic acid gel, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel.
• Wash hands immediately following application of azelaic acid gel.
• Cosmetics may be applied after the application of azelaic acid gel has dried.
• Avoid the use of occlusive dressings or wrappings.
• Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents [see Dosage and Administration (2) ] .
• Hypersensitivity If allergic reactions occur, discontinue use and consult their healthcare provider [see Warnings and Precautions (5.1) ] .
• Skin Irritation Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of azelaic acid gel, usually during the first few weeks of treatment.
• If irritation is excessive or persists, or allergic reactions occur, discontinue use and consult your physician [see Warnings and Precautions (5.2) ] .
• Hypopigmentation Advise patients to report abnormal changes in skin color to their healthcare provider [see Warnings and Precautions (5.2) ] .
• Eye and Mucous Membranes Irritation
• Avoid contact with the eyes, mouth and other mucous membranes.
• If azelaic acid gel comes in contact with the eyes, wash the eyes with large amounts of water and consult their healthcare provider if eye irritation persists [see Warnings and Precautions (5.3) ] .
• Exacerbation of Asthma Advise patients to report any worsening of asthma to their healthcare provider [see Warnings and Precautions (5.4) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Azelaic acid gel, 15% is a white to yellowish white opaque gel. Each gram of azelaic acid gel contains 0.15 gm of azelaic acid (15% w/w). Gel, 15% ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied Azelaic acid gel, 15% is a white to yellowish white opaque gel supplied in a 50 g tube (NDC 51672-1389-3). Storage and Handling
• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “Storage and Handling”.

What is in it

• Azelaic acid gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid.
• It is for topical use.
• Chemically, azelaic acid is 1,7-heptanedicarboxylic acid.
• The molecular formula for azelaic acid is C 9 H 16 O 4 .
• It has the following structure: Azelaic acid has a molecular weight of 188.22.
• It is a white, odorless crystalline solid.
• It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.
• Azelaic acid gel, 15% is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), carbomer homopolymer type C, edetate disodium, lecithin, medium-chain triglycerides, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.
• Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Azelaic Acid