Azelaic Acid Cream

Azelaic acid cream 20% is a prescription topical treatment used for mild-to-moderate inflammatory acne vulgaris. It is applied directly to the skin and is intended for acne care rather than general cosmetic use. While its exact mechanism is not fully known, it is believed to help through effects on acne-related bacteria and pore-clogging processes.

• A prescription topical treatment for inflammatory acne vulgaris
• Used directly on acne-prone areas of the skin
• Intended for dermatologic use only
• Not approved on this label for rosacea, dark spots, or scars
• Designed for regular use as directed by a healthcare provider

Azelaic acid cream 20% is generally applied as a thin film twice daily, in the morning and evening. The skin should be washed and patted dry before use, and the cream should be gently worked into the affected areas. It should only be used on the skin and kept away from the eyes, mouth, and other mucous membranes.

• Apply a thin film twice daily
• Wash and dry the skin before applying
• Gently massage into the affected areas
• Wash your hands after use
• Do not use with occlusive dressings or wrappings

Azelaic acid cream 20% can cause local skin reactions, especially where it is applied. Common side effects include itching, burning, stinging, or tingling. Some people may also notice redness, dryness, peeling, or irritation.

• Common reactions include itching, burning, stinging, or tingling
• Redness, dryness, peeling, or rash can occur
• Stop use and contact your provider if severe irritation or sensitivity develops
• Seek medical advice if you notice unusual changes in skin color
• Rinse with plenty of water if it gets into your eyes and contact a provider if irritation continues

For detailed information see Important Safety Information.

If you miss a dose, apply it at your next scheduled time. There’s no need to apply extra cream to make up for the missed application. Using more than directed can increase irritation without improving results.

• Skip the missed dose and continue as planned
• Do not apply a double amount
• Focus on staying consistent going forward
• Use reminders if needed

Some irritation can happen, especially early in treatment. If the reaction becomes uncomfortable or continues, you may need to adjust or pause use.

• Consider stopping temporarily if irritation is strong
• Avoid adding other irritating products
• Restart only if your skin tolerates it
• Contact your provider if symptoms persist

If irritation is severe or does not improve, refer to the Important Safety Information and speak with your provider.

Azelaic acid cream may cause more irritation when applied to broken or inflamed skin. It’s best to be cautious in these areas, especially when starting treatment.

If your skin is already irritated, applying the cream may increase discomfort. In that case, it’s reasonable to wait until the area has calmed down or to ask your provider how to proceed. If irritation worsens, stop use and seek guidance.

Azelaic acid cream is typically used over several weeks as part of a treatment plan. The prescribing information notes that many patients see improvement within a few weeks, but this can vary.

• Track your progress over time
• Stay consistent with your routine
• Reassess if you don’t see improvement after several weeks
• Do not stop treatment early without guidance

Your provider can help decide whether to continue or adjust your treatment.

Using more than prescribed will not make the medication work faster. It may increase the risk of irritation or side effects instead.

• More product does not improve results
• Overuse may lead to irritation
• Follow the prescribed amount
• Ask your provider before making changes

If you feel your treatment is not working as expected, your provider can review your plan.

No, Azelaic acid cream should not be applied to the eyes, inside the nose, or on the mouth. These areas are more sensitive and can become irritated.

• Avoid contact with eyes and eyelids
• Do not apply inside the nose or mouth
• Use only on external skin
• Rinse if accidental contact occurs

If irritation develops after exposure, contact your provider for advice.

If the cream gets into your eyes, rinse them thoroughly with plenty of water right away. Most mild irritation should improve after rinsing.

If eye irritation continues after flushing with water, contact a healthcare provider. Ongoing discomfort should not be ignored and may require further evaluation.

Changes in skin color, including lightening in certain areas, have been reported. If you notice unusual changes, you should contact your provider.

• Monitor your skin for noticeable changes
• Report any new or unusual discoloration
• Do not ignore persistent changes
• Ask your provider before continuing use

This is especially important if the changes are unexpected or continue over time.

If you are pregnant, planning pregnancy, or breastfeeding, you should speak with your provider before using this medication. The prescribing information recommends using it only if clearly needed.

Your provider can help weigh the potential risks and benefits based on your individual situation. Do not start or continue treatment without guidance.

The safety and effectiveness of Azelaic acid cream have not been established in children under 12 years of age. If you are considering use for a younger patient, consult a healthcare provider.

They can help determine whether this medication is appropriate or recommend alternatives based on age and medical history.

Yes, Azelaic acid cream 20% is a prescription medication. A licensed provider must evaluate your condition before it can be prescribed.

• Complete a medical assessment
• A provider reviews your information
• A prescription may be issued if appropriate
• Medication is dispensed through a pharmacy

Approval depends on your individual health profile.

Azelaic acid cream should be stored properly to maintain its effectiveness and safety.

• Store at 59°F - 86°F (15°C - 30°C)
• Protect from freezing
• Store the tube on its side
• Keep it in a safe place away from children

It’s generally not recommended to use the cream after its expiration date. The product may not perform as expected.

• Check the expiration date regularly
• Do not use expired medication unless advised
• Dispose of expired products properly
• Replace if needed

When in doubt, it’s safer to use a new supply.

There are no specific warnings in the prescribing information about alcohol use with this topical medication. However, individual responses can vary.

• No direct interaction is listed in the label
• Monitor how your skin responds during treatment
• Avoid assumptions about safety in all situations
• Ask your provider if you have concerns

For personalized advice, consult your healthcare provider.

Azelex (Azelaic Acid Cream 20%) - topical treatment for mild-to-moderate inflammatory acne vulgaris. / Source: NCBI

Link: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=0d5269d5-6555-4d2c-bc3b-df862b014275 / Published: May 2004