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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 2013
Label revision date
December 30, 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 2013
Label revision date
December 30, 2025
Manufacturer
Premier Brands of America Inc.
Registration number
M030
NDC root
56104-013

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Drug Overview

Premier CALLUS REMOVERS is an effective treatment designed to help you remove calluses, which are thickened areas of skin that can develop due to pressure and friction. The product contains salicylic acid, a medication that works by softening and breaking down the tough skin, making it easier to remove the calluses and relieve any associated pain.

In addition to removing calluses, these medicated patches also provide protection against further pressure and friction, helping to prevent the formation of new calluses. With six pads included, you have a convenient way to care for your feet and keep them comfortable.

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.

It's important to note that there are no known risks of teratogenic effects (which means causing birth defects) associated with this treatment, making it a safer option for those concerned about such risks.

Dosage and Administration

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

After 48 hours, you should remove the medicated patch. You can repeat this process every 48 hours as needed, but do not exceed 14 days of treatment. To help with the removal of the callus, you may soak it in warm water for about 5 minutes before applying the patch. Once the callus is gone, wearing the pad without the patch can help prevent it from coming back.

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 any irritated, infected, or reddened skin. These conditions can increase the risk of complications and may prevent the medication from working effectively.

Additionally, be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. It's crucial to follow these guidelines to ensure your safety and well-being. If you have any questions or concerns, please consult your healthcare provider.

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 if you have diabetes, poor blood circulation, or if your skin is irritated, infected, or reddened. If you experience ongoing discomfort, please consult your doctor or podiatrist for further advice.

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

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, it’s important to consult your doctor or a podiatrist (a foot specialist). In case of accidental swallowing, seek emergency 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. 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 symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 containing salicylic acid. They can help you understand any potential risks and guide you on the best options for your skin care during this time. 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 know that there is no specific information available about the use of Salicylic Acid callus remover patches during nursing. This means that the effects on breast milk or your nursing infant are not well-studied or documented.

As always, it's a good idea to consult with your healthcare provider before using any new products while breastfeeding to ensure the safety and well-being 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 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 using Salicylic Acid callus remover patches, there is no specific information available about how they should be used by older adults. This means that there are no special dosage adjustments or safety concerns outlined for elderly patients. However, it’s always a good idea to consult with a healthcare provider before starting any new treatment, especially if you or your loved one has underlying health conditions or is taking other medications. Your healthcare provider can help ensure that the treatment is safe and appropriate for your individual needs.

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 monitor your kidney function and make any necessary adjustments to your treatment plan.

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. 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 share your complete list of medications and any health conditions you have to 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 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 Premier CALLUS REMOVERS used for?

Premier CALLUS REMOVERS is an effective treatment for the removal of calluses and relieves pain associated with them.

What is the active ingredient in Premier CALLUS REMOVERS?

The active ingredient is Salicylic Acid, which helps in the removal of calluses.

How should I use Premier CALLUS REMOVERS?

Wash and dry the affected area, cut the medicated patch if necessary, apply it adhesive side down onto the callus, cover with a pad, and remove after 48 hours. Repeat every 48 hours 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, see your doctor or podiatrist.

Is Premier CALLUS REMOVERS safe to use during pregnancy?

The insert does not provide specific information regarding the use of salicylic acid during pregnancy.

What should I do if the product is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store Premier CALLUS REMOVERS?

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

Is there any information about using this product for elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided.

Packaging Info

Below are the non-prescription pack sizes of Salicylic Acid (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.

The medicated patch should be removed after 48 hours. This procedure may be repeated every 48 hours as needed, for a maximum duration of 14 days, or until the callus is removed. To assist in the removal of the callus, it is recommended to soak the area in warm water for 5 minutes prior to patch application.

To help prevent the recurrence of calluses, continued wearing of the pad without the medicated patch is advised.

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, poor blood circulation, or those applying it to irritated skin or any area that is infected or reddened.

Healthcare professionals should advise patients to seek medical consultation if discomfort persists, recommending that they contact their doctor or podiatrist for further evaluation.

In the event of accidental ingestion, it is imperative to obtain emergency medical assistance or contact a Poison Control Center immediately.

Patients are advised to discontinue use and consult their healthcare provider if they experience any adverse effects, although specific instructions for cessation were not provided in the available information.

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 clinical practice, if discomfort persists, patients are advised to consult their doctor or podiatrist for further evaluation. It is essential 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.

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 (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 Salicylic Acid callus removers patch in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety 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, the potential risks to fetal outcomes remain unclear. Healthcare professionals should exercise caution when considering the use of salicylic acid in pregnant patients, as the absence of safety information necessitates a careful assessment of the benefits versus risks. Women of childbearing potential should be advised to discuss their pregnancy status and any potential plans for pregnancy with their healthcare provider before initiating treatment with salicylic acid.

Lactation

There is no information available regarding the use of Salicylic Acid 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

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

Prompt action 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 and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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.

Patient Counseling

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

Patients should be informed that this 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 or podiatrist 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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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.