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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 2017
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 2017
Label revision date
December 29, 2025
Manufacturer
Discount Drug Mart
Registration number
M030
NDC root
53943-004

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Drug Overview

Salicylic acid is a medication commonly used for the removal of 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 the callus. In addition to its primary function, salicylic acid also helps relieve pain associated with calluses and provides protection against further pressure and discomfort.

You may find salicylic acid in the form of medicated patches, which are designed to be applied directly to the affected area. These patches contain the active ingredient that targets the callus, promoting its removal and helping to restore smoother skin.

Uses

If you're dealing with calluses, this treatment can help by effectively removing them. Calluses are thickened areas of skin that can cause discomfort, and by getting rid of them, you can also relieve any associated pain. This product is specifically designed to target and eliminate calluses, making your skin smoother and more comfortable.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other potential harmful effects unrelated to birth defects) with this treatment. You can use it with confidence for your callus removal needs.

Dosage and Administration

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

You should leave the patch on for 48 hours. After this time, carefully remove it. If needed, you can repeat this process every 48 hours for up to 14 days, or until the callus is completely removed. 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

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. Following these guidelines is important to ensure your safety and well-being.

Side Effects

It's important to be aware of some key warnings and precautions when using this product. It is for external use only, so avoid applying it to areas that are irritated, infected, or reddened. If you have diabetes or poor blood circulation, you should not use this product.

If you experience any discomfort that lasts, please consult your doctor. Additionally, keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that are irritated, infected, or reddened. If you have diabetes or poor blood circulation, do not use this product.

If you experience any discomfort that continues, it’s important to consult your doctor. Always keep this product out of reach of children. In the event that it is swallowed, seek medical help immediately or contact a Poison Control Center.

Overdose

If you or someone else has swallowed too much of this 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.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. Always err on the side of caution and get help if you suspect an overdose has occurred. Your safety is the top priority, so don’t hesitate to reach out for assistance.

Pregnancy Use

When it comes to using salicylic acid during pregnancy, there is 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 products that contain salicylic acid. They can help you understand any potential risks and guide you on the best choices for your health and your baby's well-being. Always prioritize open communication with your doctor regarding any medications or treatments during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of Salicylic Acid medicated callus remover patches during lactation. This means that the effects on breast milk or nursing infants have not been studied or documented.

As always, it's a good idea to consult with your healthcare provider before using any medication while breastfeeding 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

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, it’s important to consult with a healthcare provider before starting the medication. 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 for your liver health. They can help determine the best approach for your treatment based on your individual circumstances.

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° 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 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 used for?

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

How do I use Salicylic Acid medicated patches?

Wash the affected area and dry it thoroughly. Cut the medicated patch if necessary, apply it adhesive side down onto the callus, cover it with a pad, and remove it after 48 hours.

How often can I use the Salicylic Acid 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?

If discomfort persists, ask your doctor for advice.

Is Salicylic Acid safe to use during pregnancy?

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

What precautions should I take when using Salicylic Acid?

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 Salicylic Acid?

Store Salicylic Acid between 15°C to 30°C (59° 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 associated with this drug.

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 and those who exhibit poor blood circulation. It should not be applied to irritated skin or any areas that are infected or reddened.

Healthcare professionals are advised to instruct patients to seek medical advice if discomfort persists after application. Additionally, it is imperative to keep this product out of the 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 consult their healthcare provider. It is crucial 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 are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary 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 contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information 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

The safety of salicylic acid during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when considering the administration of salicylic acid to pregnant patients.

Due to the lack of available safety data, it is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be informed of the absence of specific safety information and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no information available regarding the use of Salicylic Acid medicated callus removers patch in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating patients.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 prescribing 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 may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control experts is recommended to guide treatment decisions and ensure optimal patient care.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 encourage patients to consult their doctor if discomfort persists after using the medication. This ensures that any underlying issues can be addressed appropriately.

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 should be observed to ensure the integrity of the product throughout its shelf life.

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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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.