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Salicylic Acid

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Active ingredient
Salicylic Acid 400 mg/1 g
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
December 30, 2025
Active ingredient
Salicylic Acid 400 mg/1 g
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
December 30, 2025
Manufacturer
Chain Drug Marketing Association
Registration number
M030
NDC root
83324-230

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Drug Overview

Salicylic Acid 40% is a medicated treatment specifically designed for the effective removal of calluses, which are thickened areas of skin that can develop due to pressure and friction. By using this product, you can relieve pain associated with calluses as it works to break down and remove the hardened skin.

This treatment comes in the form of pads and patches, making it easy to apply directly to the affected area. Salicylic acid (a type of medication that helps to exfoliate and soften the skin) is the active ingredient that helps to achieve smoother skin and alleviate discomfort caused by calluses.

Uses

If you're dealing with calluses, this treatment can help you by effectively removing them. Calluses are thickened areas of skin that can develop due to friction or pressure, and they can be uncomfortable or painful. By using this product, you can relieve the pain associated with calluses, making your skin feel smoother and more comfortable.

This treatment is specifically designed for the removal of calluses, helping to restore the natural texture of your skin. If you're looking for relief from the discomfort caused by calluses, this could be a suitable option for you.

Dosage and Administration

To start treating your callus, first wash the affected area and make sure it is completely dry. If the medicated patch is too large, you can cut it to fit the size of your callus. Once it’s the right size, carefully stick the patch directly over the callus. To keep it in place, cover the patch with a pad.

After 48 hours, you should remove the medicated patch. If the callus is still there, you can repeat this process every 48 hours as needed, but do not exceed 14 days of treatment. For better results, you may soak the callus in warm water for about 5 minutes before applying the patch, as this can help with the removal process.

What to Avoid

It's important to be cautious when considering this medication. You should not use it if you are diabetic, have poor blood circulation, or if you have irritated skin or any area that is infected or reddened. These conditions can lead to complications or reduce the effectiveness of the treatment. Always consult with your healthcare provider if you have any questions or concerns about your health and the use of this medication.

Side Effects

For your safety, this product is for external use only. You should not use it if you have diabetes, poor blood circulation, or if your skin is irritated, infected, or reddened. If you experience any discomfort that continues, it's important to stop using the product and consult a doctor.

Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. You should not use it if you have diabetes, poor blood circulation, or if your skin is irritated, infected, or reddened.

If you experience any discomfort that continues, stop using the product and consult your doctor. It's also important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available regarding the use of this medication during pregnancy. Fortunately, there are no safety concerns or contraindications mentioned that would suggest it is unsafe for you during this time. Additionally, there are no dosage modifications required for pregnant individuals, and no special precautions have been noted for its use while pregnant.

As always, it's best to discuss any medications with your healthcare provider to ensure they are appropriate for your individual situation.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk production and the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider for personalized advice and to discuss any concerns you may have about medications while breastfeeding. They can help you weigh the benefits and risks based on your individual situation.

Pediatric Use

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

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you are undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C to 30°C (59°F to 86°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is Salicylic Acid 40% used for?

Salicylic Acid 40% is used for the removal of calluses and relieves pain by removing them.

How should I use the medicated patches?

Wash the affected area and dry it thoroughly. Cut the medicated patch to fit the callus if necessary, adhere it directly over the callus, cover it with a pad, and remove it after 48 hours.

How often can I use the medicated patches?

You can repeat the procedure every 48 hours as needed for up to 14 days until the callus is removed.

Are there any contraindications for using this product?

Do not use Salicylic Acid 40% if you are diabetic, have poor blood circulation, or if the skin is irritated, infected, or reddened.

What should I do if discomfort persists?

Stop use and ask a doctor if discomfort persists.

Is this product safe for use during pregnancy?

No specific information is provided regarding the use of Salicylic Acid 40% during pregnancy, and no safety concerns are mentioned.

What precautions should I take when using this product?

For external use only. Keep out of reach of children, and if swallowed, get medical help or contact a Poison Control Center immediately.

What is the storage requirement for this product?

Store Salicylic Acid 40% between 15°C to 30°C (59°F to 86°F).

Packaging Info

Below are the non-prescription pack sizes of Salicylic Acid (medicated callus removers). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Salicylic Acid.
Details

Drug Information (PDF)

This file contains official product information for Salicylic Acid, 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 removal of calluses. It provides relief from pain associated with calluses by effectively removing them.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The affected area should be washed and dried thoroughly prior to application. If necessary, the medicated patch may be cut to fit the size of the callus. The medicated patch should then be carefully adhered directly over the callus. Following application, the medicated patch must be covered with a pad to ensure proper adherence and protection.

The medicated patch should remain in place for a duration of 48 hours. After this period, the patch must be removed. This procedure may be repeated every 48 hours as needed, for a maximum duration of 14 days, or until the callus is effectively removed.

To enhance the efficacy of the treatment, it is recommended to soak the callus in warm water for 5 minutes prior to the application of the medicated patch.

Contraindications

Use is contraindicated in the following situations:

  • Patients with diabetes, due to potential complications related to blood sugar management.

  • Individuals with poor blood circulation, as this may exacerbate underlying conditions.

  • Application on irritated skin or on any area that is infected or reddened, to prevent further irritation or infection.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with diabetes or those who exhibit poor blood circulation. It should not be applied to irritated skin or any area that is infected or reddened.

Healthcare professionals should advise patients to discontinue use and seek medical advice if discomfort persists.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated in individuals who are diabetic or have poor blood circulation. Additionally, the product should not be applied to irritated skin or any area that is infected or reddened.

In the event that discomfort persists after application, patients are advised to stop use and consult a healthcare professional.

It is important to keep the product out of reach of children. If the product is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Salicylic Acid (medicated callus removers). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Salicylic Acid.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients may use this medication as no specific information regarding its use during pregnancy has been provided. There are no safety concerns or contraindications associated with the use of this medication in pregnant individuals. Additionally, no dosage modifications are specified for pregnant patients, and no special precautions are noted for its use during pregnancy. As always, healthcare professionals should consider the individual circumstances of each patient when prescribing medications during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. The potential risks and benefits should be carefully weighed in the context of the individual patient's situation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

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

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be informed that the medication is not suitable for individuals with diabetes or those who have poor blood circulation. It is also important to counsel patients against using the medication on irritated skin or on any areas that are infected or reddened.

Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if discomfort persists. This guidance is essential for ensuring patient safety and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within a temperature range of 15°C to 30°C (59°F to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Salicylic Acid, 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 Salicylic Acid, 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.