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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
December 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
December 29, 2025
Manufacturer
Foodhold USA
Registration number
M030
NDC root
41520-570
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

CareOne is a medicated treatment designed specifically for the removal of calluses, which are thickened areas of skin that can develop due to pressure and friction. It contains salicylic acid, a key ingredient that helps to soften and dissolve the callus, providing relief from pain associated with these skin growths.

This effective callus removal solution comes with six patches and four medicated pads, making it easy to use at home. By using CareOne, you can help protect your skin from further irritation while addressing the discomfort caused by calluses.

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 not only get rid of the calluses but also relieve the pain they may be causing you.

This solution is specifically designed for the removal of calluses, making it a targeted option for those looking to improve their skin comfort and appearance.

Dosage and Administration

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

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 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, as it may not be safe for your condition. Additionally, if you have poor blood circulation, it’s important not to use this product, as it could worsen your situation. Never apply it to irritated skin or any areas that are infected or reddened, as this could lead to further complications. Always prioritize your health and consult with a healthcare professional if you have any concerns about using this medication.

Side Effects

This product is intended for external use only. You should not use 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 intended for external use only, so please avoid applying it to any internal areas. If you have diabetes or poor blood circulation, it’s important not to use this product. Additionally, do not apply it to any irritated, infected, or reddened skin, as this could worsen your condition.

If you experience ongoing discomfort after using the product, stop using it and consult your doctor for further advice. In the event that the product is swallowed, seek medical assistance immediately or contact a Poison Control Center for help. Your safety is a priority, so please take these precautions seriously.

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 symptoms that are not typical for the medication.

Remember, it's always better to be safe and get professional advice if you suspect an overdose. Don't hesitate to reach out for help.

Pregnancy Use

Currently, there is no available information 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 it is safe for you and 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 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 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

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 all medications being taken, as this can help prevent potential interactions and ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual safety considerations and monitoring practices for patients with renal impairment (kidney issues) are not detailed.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and appropriate for you.

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 regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 CareOne?

CareOne is a medicated callus remover that contains salicylic acid, designed for the effective removal of calluses.

How does CareOne work?

CareOne works by using salicylic acid to relieve pain and remove calluses, protecting against pressure and friction.

How should I use CareOne?

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

Who should not use CareOne?

Do not use CareOne 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, stop use and ask a doctor for advice.

What should I do if CareOne is swallowed?

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

Is CareOne safe to use during pregnancy or while nursing?

There is no specific information regarding the use of CareOne during pregnancy or lactation.

What are the storage conditions for CareOne?

Store CareOne 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 must be applied directly onto the callus. Following application, the medicated patch should be covered with a pad to secure it in place.

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 enhance the efficacy of the treatment, it is recommended to soak the callus in warm water for 5 minutes prior to the application of the medicated patch.

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 advised against use, as this may exacerbate their condition and lead to complications.

Application is contraindicated on irritated skin or any area that is infected or reddened, as this may worsen the irritation or promote further infection.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with diabetes or those who exhibit poor blood circulation. It is imperative that the product not be applied to irritated skin or any areas that are infected or reddened, as this may exacerbate existing conditions.

Healthcare professionals should advise patients to discontinue use and seek medical advice if discomfort persists following application. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

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, immediate medical help 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 (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

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 therapeutic response, 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. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering the use of this product in pregnant patients. Healthcare professionals should exercise caution and consider the absence of data when advising women of childbearing potential regarding the use of this medication 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. The potential risks and benefits should be carefully weighed 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 clinical trials for 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 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 instruct patients to discontinue use and consult a doctor if discomfort persists. This guidance is essential to ensure the safe 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, which may compromise the product's quality.

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.