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Salicylic Acid

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Active ingredient
Salicylic Acid 40 mg/4 1
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2012
Label revision date
December 29, 2025
Active ingredient
Salicylic Acid 40 mg/4 1
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 2012
Label revision date
December 29, 2025
Manufacturer
Harris Teeter, LLC
Registration number
M030
NDC root
69256-031

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Drug Overview

Salicylic acid is a medication commonly used in products designed to remove calluses, which are thickened areas of skin that can develop due to pressure or friction. It works effectively by softening and breaking down the tough skin, making it easier to remove calluses and relieve any associated pain. By using salicylic acid, you can protect your skin from further pressure and discomfort.

These medicated callus removers, available in patches and pads, provide a convenient way to treat calluses at home. If you're dealing with painful calluses, salicylic acid can help restore comfort and improve the appearance of your skin.

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 sometimes cause discomfort. 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 a solution to ease the discomfort caused by calluses, this product may be a good option for you.

Dosage and Administration

To start using the medicated patch for your callus, first wash the affected area and make sure it is completely dry. If the patch is too large, you can cut it to fit the size of your callus. Next, place the adhesive side of the patch directly onto the callus and cover it with a pad to keep it in place.

You should leave the patch on for 48 hours before removing it. If the callus is still present, you can repeat this process every 48 hours as needed, but do not use it for more than 14 days. To help with the removal of the callus, you may soak it in warm water for about 5 minutes before applying the patch.

What to Avoid

You should avoid using this medication if you are diabetic or have poor blood circulation, as it may not be safe for you. Additionally, do not apply it to any irritated skin or areas that are infected or reddened. These precautions are important to ensure your safety and well-being while using this product.

Side Effects

This product is intended for external use only. You should avoid using 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.

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 areas of your body that are infected, reddened, or irritated. If you have diabetes or poor blood circulation, you should not use this product.

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 act quickly. You should seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don't wait for symptoms to worsen; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure safety.

Pregnancy Use

When it comes to using Salicylic Acid during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby by seeking professional advice.

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 and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally 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

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for ensuring safety and effectiveness. Always keep them informed about any other medications or health issues to avoid potential interactions or complications.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 15°C to 30°C (59°F to 86°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Salicylic Acid used for?

Salicylic Acid 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. If necessary, cut the medicated patch to fit the callus, apply it adhesive side down, 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 Salicylic Acid?

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

What should I do if discomfort persists?

Stop using the product and ask a doctor if discomfort persists.

Is Salicylic Acid safe to use during pregnancy?

The drug insert does not provide specific information regarding the use of Salicylic Acid during pregnancy.

What precautions should I take regarding children?

Keep Salicylic Acid out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

What is the storage requirement for Salicylic Acid?

Store Salicylic Acid 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 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 adhesive side of the medicated patch should be applied directly onto the callus. Following application, the medicated patch must be covered with a pad to ensure proper adherence.

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 facilitate the removal of the callus, soaking the area in warm water for 5 minutes prior to patch application is recommended.

Contraindications

Use is contraindicated in the following situations:

Patients with diabetes should not use this product due to the potential for adverse effects on glycemic control.

Individuals with poor blood circulation are also contraindicated, as the product may exacerbate their condition.

Application is not recommended on irritated skin or on any areas that are infected or reddened, as this may lead to further irritation or complications.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with diabetes, those who have poor blood circulation, and 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

For external use only. Patients should not use this product if they are diabetic, have poor blood circulation, or if applied to irritated skin or any area that is infected or reddened.

In the event that discomfort persists, patients are advised to stop use and consult a doctor. It is important to keep this product out of reach of children. If swallowed, patients should seek medical help or contact a Poison Control Center immediately.

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 local Poison Control Center should be contacted without delay.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of Salicylic Acid during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no documented dosage modifications or special precautions recommended for this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of Salicylic Acid in women of childbearing potential. It is advisable to exercise caution and to discuss any potential risks with patients who are pregnant or planning to become pregnant.

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 evaluated 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 the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 after application. This guidance is essential to ensure 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 integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance and safety.

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.

Learn more in our Editorial Policy

Last AI update:

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.