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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 2018
Label revision date
December 31, 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 2018
Label revision date
December 31, 2025
Manufacturer
LEADER/ Cardinal Health 110, Inc.
Registration number
M030
NDC root
70000-0333

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Drug Overview

LEADER Medicated Callus Removers is a treatment designed to help you effectively remove calluses, which are thickened areas of skin that can develop due to pressure or friction. This product contains 40% salicylic acid, a medication that works by softening and breaking down the tough skin of calluses, making it easier to remove them.

In addition to its callus removal properties, LEADER Medicated Callus Removers also provides relief from pain associated with calluses. The product comes with four medicated patches and six protective pads, ensuring you have the necessary tools to manage and treat your calluses comfortably.

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 that pain and restore smoother skin.

This treatment is specifically designed for the removal of calluses, making it a targeted solution for anyone looking to alleviate discomfort caused by these skin issues. Enjoy the relief and comfort that comes with healthier skin!

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 ongoing discomfort while using the product, it's important to stop and consult a doctor.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

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

If you experience ongoing discomfort after using the product, stop using it 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.

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, acting quickly can make a significant difference in the outcome.

Pregnancy Use

Currently, there is no information available about the use of Salicylic Acid Medicated Callus Removers during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure your safety and the safety of your baby.

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 baby 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 benefits and risks 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 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 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 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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 might be 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 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 LEADER Medicated Callus Removers used for?

LEADER Medicated Callus Removers are used for the effective removal of calluses and to relieve pain associated with them.

What is the active ingredient in LEADER Medicated Callus Removers?

The active ingredient is Salicylic Acid at a concentration of 40%.

How should I use LEADER Medicated Callus Removers?

Wash and dry the affected area, cut the medicated patch if necessary, apply it adhesive side down onto the callus, cover it with a protective pad, and remove it after 48 hours. Repeat as needed for up to 14 days.

Are there any contraindications for using this product?

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

What should I do if discomfort persists?

If discomfort persists, stop use and ask a doctor.

Is this product safe for children?

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

What are the storage conditions for LEADER Medicated Callus Removers?

Store the product between 15°C to 30°C (59°F to 86°F).

Is there any information regarding use during pregnancy or lactation?

No specific information is provided regarding the use of this product during pregnancy or lactation.

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 potential complications associated with glycemic control.

Individuals with poor blood circulation are advised against use, as this may exacerbate their condition and lead to further complications.

Application is contraindicated on irritated skin or any area that is infected or reddened, as this may worsen the 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 areas that are 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, medical help should be sought immediately, or contact a Poison Control Center right away.

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

There is currently no information available regarding the use of Salicylic Acid Medicated Callus Removers during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution and consider the potential risks versus benefits when prescribing this medication to women of childbearing potential. Further studies may be necessary to elucidate any potential fetal impacts associated with the use of this product 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. It is recommended to weigh the potential benefits against any unknown risks to breastfed infants.

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 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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised 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.

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 ensured to prevent exposure to extreme temperatures.

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.