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Azelaq

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Active ingredient
Salicylic Acid 5 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
November 10, 2025
Active ingredient
Salicylic Acid 5 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
November 10, 2025
Manufacturer
METHODIQ INC.
Registration number
M006
NDC root
87110-003

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Drug Overview

Azelaq is a topical treatment designed to help manage and treat acne. It contains salicylic acid, which works by clearing existing acne blemishes and blackheads while also helping to prevent the formation of new ones. This makes it a useful option for those looking to improve their skin's appearance and reduce breakouts.

Uses

If you're dealing with acne, this treatment can help manage and treat your condition effectively. It works by clearing existing acne blemishes and blackheads, giving your skin a clearer appearance. Additionally, it helps prevent the formation of new acne blemishes and blackheads, making it a proactive choice for maintaining healthier skin.

Dosage and Administration

Before using this product, make sure to clean the skin thoroughly. Once your skin is clean, apply a thin layer of the product to the entire affected area. You can do this one to three times a day, depending on your needs and your doctor's advice.

To avoid excessive drying of your skin, it's best to start with just one application each day. If your skin tolerates it well, you can gradually increase to two or three applications daily. However, if you notice any bothersome dryness or peeling, reduce your application to once a day or even every other day. This way, you can find the right balance for your skin while still getting the benefits of the treatment.

What to Avoid

It's important to be aware of certain precautions when using this product. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. This is crucial for your safety.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this product. However, always use it as directed and stay informed about any potential changes in guidelines. Your health and safety should always come first.

Side Effects

When using this product, it's important to know that skin irritation and dryness may occur, especially if you are using another topical acne medication at the same time. To minimize the risk of irritation, it’s best to use only one topical acne treatment at a time. Remember, this product is for external use only.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that are not on the skin. If you are using another topical acne medication, be cautious, as using both at the same time can increase the risk of skin irritation and dryness. To minimize this risk, it’s best to use only one topical acne treatment at a time.

Make sure to keep this product out of reach of children. If it is accidentally swallowed, seek medical help immediately or contact a Poison Control Center for assistance. Your safety is important, so please follow these precautions carefully.

Overdose

If you or someone else has swallowed this product, it’s important to seek medical help immediately or contact a Poison Control Center. Acting quickly can make a significant difference in managing the situation effectively.

Signs of an overdose may not always be obvious, so it's crucial to be vigilant. If you notice unusual symptoms or feel unwell after taking the product, don’t hesitate to reach out for assistance. Remember, your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. The use of this product is generally not recommended due to potential risks to your developing baby. Specifically, there may be risks associated with salicylic acid, so it's crucial to consult your healthcare provider for personalized advice.

Before using this product, please seek medical guidance, as your doctor may suggest adjustments to the dosage based on your individual situation. Always prioritize your health and the health of your baby by discussing any medications or treatments with your healthcare professional.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows the product, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health needs. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed to protect the contents from light and contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply this medication topically, covering the entire affected area with a thin layer. Start with one application each day, and if necessary, you can gradually increase to two or three times daily, or follow your doctor's instructions.

FAQ

What is Azelaq used for?

Azelaq is used for the management and treatment of acne. It helps clear acne blemishes and blackheads and prevents the development of new ones.

How should I apply Azelaq?

Clean the skin thoroughly before applying Azelaq. Cover the entire affected area with a thin layer one to three times daily, starting with one application daily and gradually increasing if needed.

What should I do if I experience dryness or irritation?

If you experience bothersome dryness or peeling, reduce the application to once a day or every other day.

Is Azelaq safe to use during pregnancy?

The safety of Azelaq during pregnancy has not been established, and its use is not recommended due to potential risks to the fetus. Consult your healthcare provider for advice.

What should I do if Azelaq is swallowed?

If Azelaq is swallowed, get medical help or contact a Poison Control Center immediately.

What precautions should I take while using Azelaq?

Use Azelaq for external use only and keep it out of reach of children. Avoid using it simultaneously with other topical acne medications to reduce the risk of skin irritation.

How should I store Azelaq?

Store Azelaq at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed. Discard it after opening.

Packaging Info

Below are the non-prescription pack sizes of Azelaq (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Azelaq.
Details

Drug Information (PDF)

This file contains official product information for Azelaq, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the management and treatment of acne. It effectively clears existing acne blemishes and blackheads while also helping to prevent the development of new acne blemishes and blackheads.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. The recommended application involves covering the entire affected area with a thin layer. This can be done one to three times daily, depending on the patient's needs and the physician's guidance.

It is advisable to initiate treatment with one application per day to minimize the risk of excessive drying of the skin. Based on the patient's response, the frequency may be gradually increased to two or three times daily as necessary or as directed by a healthcare provider.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the frequency of application to once a day or every other day to alleviate these symptoms.

Contraindications

There are no specific contraindications identified for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid concurrent use of this product with other topical acne medications, as this may increase the likelihood of skin irritation and dryness. In the event that irritation occurs, it is recommended that patients limit their use to one topical acne medication at a time to mitigate adverse effects.

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the case of accidental swallowing, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. The use of this product in conjunction with other topical acne medications may increase the likelihood of skin irritation and dryness. In clinical practice, if patients experience irritation, it is recommended that they discontinue the use of additional topical acne treatments and limit their regimen to one topical acne medication at a time to mitigate adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Azelaq (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Azelaq.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that the product is swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this product. The use of this product is not recommended during pregnancy due to potential risks to the fetus. There may be risks associated with the use of salicylic acid during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for personalized advice. Pregnant women should seek medical advice before using this product, and dosage may need to be adjusted based on individual circumstances.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. It is recommended that individuals do not wait for symptoms to appear before seeking help, as timely intervention can significantly influence the outcome.

Healthcare providers should be prepared to assess the situation and provide appropriate management based on the specific circumstances of the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Additionally, it is important for healthcare providers to discuss the potential for skin irritation and dryness associated with the use of this product. Patients should be informed that the likelihood of these side effects increases if they are using another topical acne medication concurrently. Therefore, if irritation occurs, patients should be counseled to limit their use to one topical acne medication at a time to minimize the risk of adverse effects.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin layer covering the entire affected area one to three times daily. Patients should begin with one application per day and may gradually increase to two or three times daily as needed or as directed by a healthcare professional.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Azelaq, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Azelaq, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.