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Salicylic Acid

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Active ingredient
Salicylic Acid 17 g/100 mL
Other brand names
Dosage form
Liquid
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 17 g/100 mL
Other brand names
Dosage form
Liquid
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
70000-0332

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Drug Overview

LEADER Corn & Callus Remover is a liquid formulation that contains 17% salicylic acid, a medication that helps in the removal of corns and calluses. This product works by softening and breaking down the thickened skin, which not only helps to eliminate these skin issues but also provides relief from the pain they can cause.

In addition to its active ingredient, LEADER Corn & Callus Remover is designed to safely remove corns and calluses while cushioning and protecting the affected areas. Each package includes three cushions to enhance comfort during use.

Uses

You can use this medication to help remove corns and calluses, which are thickened areas of skin that can develop on your feet or hands. By getting rid of these growths, the treatment also helps relieve any pain you may be experiencing due to them. This can make walking or using your hands more comfortable.

It's important to note that there are no known harmful effects on developing babies (teratogenic effects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

To start treating your corn or callus, first wash the affected area with soap and water, then dry it thoroughly. Using the provided applicator, apply one drop of the medication at a time directly onto the corn or callus, ensuring that it is completely covered. Allow the area to dry after each application.

For added comfort, you can use cushions that have a hole in the center, which will help relieve pressure on the corn or callus. These cushions can be purchased separately if needed. You should repeat this application process once or twice a day, as necessary, for up to 14 days, or until the corn or callus is completely removed.

What to Avoid

It's important to use this product safely. You should avoid applying it to irritated skin or any areas that are infected or reddened. If you have diabetes or poor blood circulation, do not use this product unless you have received specific advice and supervision from a doctor or podiatrist. Following these guidelines will help ensure your safety and well-being while using this product.

Side Effects

When using this product, it's important to be aware of certain precautions. This product is for external use only, so avoid applying it to irritated, infected, or reddened skin. If you have diabetes or poor blood circulation, consult your doctor or podiatrist before use. Be careful to keep the product away from your eyes and avoid inhaling any vapors. If the product does get into your eyes, rinse them with water for 15 minutes.

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

Warnings and Precautions

This product is for external use only, so please avoid applying it to your skin if it is irritated, infected, or reddened. If you have diabetes or poor blood circulation, consult your doctor or podiatrist before using this product. Always keep the bottle tightly capped and store it at room temperature, away from heat and flames, as it is flammable.

While using this product, be careful to avoid contact with your eyes and do not inhale the vapors. If the product accidentally gets into your eyes, rinse them with water for 15 minutes. Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

In any case of suspected overdose, acting quickly is crucial. Don’t wait for symptoms to worsen; getting prompt assistance can make a significant difference in the outcome. Always prioritize safety and reach out for help right away.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with certain products. You should avoid using this product if you have diabetes or poor blood circulation unless your doctor or podiatrist has advised you otherwise. Remember, this product is for external use only, so keep it away from fire or flames, and always store it out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Always consult your healthcare provider for personalized advice regarding any medications or products during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned 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 swallows any of 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 the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it’s important to consult with a healthcare professional for personalized advice. They can help determine the best approach to medication management, considering any unique health needs or conditions that may be present.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 if you have hepatic impairment (liver issues).

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 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. 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 safety and effectiveness of your product, it’s important to store it properly. Keep the bottle tightly capped and store it at room temperature, ideally between 20°C and 25°C (68°F and 77°F). Make sure to keep it away from heat sources and any open flames, as these can pose a fire hazard.

Additionally, always close the bottle tightly after use to prevent solidification, which can affect the product's performance. If you need to store it for an extended period, choose a cool place to maintain its quality. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is LEADER Corn & Callus Remover used for?

LEADER Corn & Callus Remover is used for the removal of corns and calluses, relieving pain associated with them.

What is the active ingredient in LEADER Corn & Callus Remover?

The active ingredient is Salicylic Acid 17%, which helps in the removal of corns and calluses.

How should I apply LEADER Corn & Callus Remover?

Wash the affected area, dry it thoroughly, and apply one drop at a time to cover each corn or callus. Let it dry and use cushions to relieve pressure.

How often can I use LEADER Corn & Callus Remover?

You can repeat the application once or twice daily as needed for up to 14 days, or until the corn or callus is removed.

Are there any contraindications for using this product?

Do not use LEADER Corn & Callus Remover on irritated skin, infected areas, or if you are diabetic or have poor blood circulation without a doctor's advice.

What precautions should I take when using this product?

Avoid contact with eyes and inhaling vapors. If the product gets into your eyes, flush with water for 15 minutes.

Is LEADER Corn & Callus Remover safe for children?

Keep LEADER Corn & Callus Remover out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

What should I do if I experience side effects?

If you experience any adverse effects, discontinue use and consult a healthcare professional.

How should I store LEADER Corn & Callus Remover?

Store the product tightly capped at room temperature, away from heat and fire, and between 20°C - 25°C (68°F - 77°F).

Packaging Info

Below are the non-prescription pack sizes of Salicylic Acid (liquid corn and callus remover). 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 corns and calluses. It provides relief from pain associated with these conditions by effectively removing the corns and calluses.

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. One drop of the product should be applied at a time using the provided applicator, ensuring that each corn or callus is sufficiently covered. After application, the area should be allowed to dry completely.

To relieve pressure on the corn or callus, it is recommended to use cushions with a hole centered over the affected area. Additional cushions may be purchased separately if needed.

This procedure may be repeated once or twice daily as necessary, for a maximum duration of 14 days, or until the corn or callus is removed.

Contraindications

Use is contraindicated in the following situations:

  • Application on irritated skin is prohibited due to the potential for exacerbating the condition.

  • Application on infected or reddened areas is contraindicated to prevent further irritation or complications.

  • Use is not recommended for individuals with diabetes or poor blood circulation, unless under the guidance and supervision of a healthcare professional, due to the increased risk of adverse effects.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame. It is essential to cap the bottle tightly and store it at room temperature, away from heat sources.

The product should not be applied to irritated skin or any area that is infected or reddened. Caution is advised for individuals with diabetes or poor blood circulation; use is only recommended under the guidance and supervision of a healthcare professional, such as a doctor or podiatrist.

While using this product, it is crucial to avoid contact with the eyes and to refrain from inhaling vapors. In the event that the product comes into contact with the eyes, it is imperative to flush the eyes with water for at least 15 minutes.

This product should be kept out of reach of children. If ingested, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use on irritated skin or on any area that is infected or reddened. Additionally, individuals who are diabetic or have poor blood circulation should not use this product unless advised and supervised by a healthcare professional, such as a doctor or podiatrist.

While using this product, it is important to avoid contact with the eyes and to refrain from inhaling vapors. In the event that the product comes into contact with the eyes, it is recommended to flush the eyes with water for at least 15 minutes.

This product should be kept out of reach of children. If ingested, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 (liquid corn and callus remover). 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

Pregnant patients should be advised against the use of this product, particularly if they have diabetes or poor blood circulation, unless under the guidance and supervision of a healthcare professional. The product is intended for external use only, and caution should be exercised to avoid exposure to fire or flame due to its flammability. Additionally, it is crucial to keep the product out of reach of children, as ingestion may necessitate immediate medical attention or contact with a Poison Control Center. Given the lack of specific data regarding the safety and efficacy of this product during pregnancy, healthcare providers should carefully consider the potential risks and benefits before recommending its use to pregnant patients.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding or effects on breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert text. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

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

Patients should be instructed not to use the product on irritated skin or on any area that is infected or reddened. It is also important to inform patients that individuals with diabetes or poor blood circulation should not use the product unless under the advice and supervision of a doctor or podiatrist.

While using this product, patients should be cautioned to avoid contact with their eyes and to refrain from inhaling vapors. In the case of accidental contact with the eyes, patients should flush the eyes with water for 15 minutes and seek medical attention if irritation persists.

Storage and Handling

The product is supplied in a tightly capped bottle, which must be stored at room temperature, specifically between 20°C and 25°C (68°F and 77°F). It is essential to keep the container closed tightly to prevent solidification. Additionally, the product should be kept away from heat sources and any open flames to ensure safety and integrity. For optimal storage conditions, it is recommended to place the product in a cool location, away from fire or flame.

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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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.