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Salicylic Acid

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This product has been discontinued

Active ingredient
Salicylic Acid 40 mg/24 1
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
October 15, 2024
Active ingredient
Salicylic Acid 40 mg/24 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 2018
Label revision date
October 15, 2024
Manufacturer
Hudson Health LLC
Registration number
M028
NDC root
72446-009

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Drug Overview

Comfortzone medicated plantar wart remover is a treatment specifically designed for the removal of plantar warts, which are painful growths that appear on the bottom of the foot. This product contains salicylic acid, an active ingredient that helps to effectively remove these warts.

The remover comes in a convenient format with medicated patches and concealing pads, allowing you to treat the wart while also protecting the area. Its maximum strength formula is designed to be mess-free, making it easier for you to manage your treatment.

Uses

If you have plantar warts, which are painful growths located on the bottom of your foot, this treatment can help remove them. These warts are typically identified by their specific location, tenderness, and the way they disrupt your footprint pattern.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this treatment. This makes it a safe option for addressing plantar warts without concerns about these specific risks.

Dosage and Administration

To start treating your wart, first wash the affected area thoroughly. You can soak the wart in warm water for about 5 minutes to help soften it. After soaking, make sure to dry the area completely. If the medicated patches are too large, you can cut them to fit the size of your wart.

Next, apply the adhesive side of the patch directly onto the wart. To keep the patch in place and to conceal the area, cover it with pads. You should repeat this process every 48 hours as needed, continuing until the wart is removed, but no longer than 12 weeks.

What to Avoid

You should avoid using this product if you are diabetic or have poor blood circulation unless a doctor or podiatrist has advised you to do so. It's also important not to apply it to any irritated, infected, or reddened skin. Additionally, refrain from using it on genital warts, warts on the face, moles, birthmarks, or warts that have hair growing from them. Lastly, do not use this product on mucous membranes, as it can cause irritation or other issues. Always prioritize your health and consult a healthcare professional if you have any concerns.

Side Effects

You should only use this product externally and avoid it if you have diabetes or poor blood circulation unless your doctor or podiatrist advises otherwise. It's important not to apply it to irritated, infected, or reddened skin, as well as on genital warts, facial warts, moles, birthmarks with hair, or mucous membranes.

Keep this and all medications out of children's reach. If swallowed, seek medical help or contact a Poison Control Center immediately. If you experience ongoing discomfort, please consult your doctor or podiatrist.

Warnings and Precautions

This product is for external use only. You should not use it if you have diabetes or poor blood circulation unless your doctor or podiatrist has advised you to do so. Avoid applying it to irritated, infected, or reddened skin, as well as on genital warts, facial warts, moles, birthmarks, or warts with hair growing from them. It should also not be used on mucous membranes (the moist tissue lining certain body parts).

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center immediately. If you experience ongoing discomfort while using this product, stop using it and reach out to your doctor or podiatrist for further guidance.

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. Acting quickly can make a significant difference in the outcome.

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, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

When it comes to using salicylic acid during pregnancy, there is currently 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 weigh the potential risks and benefits based on your individual situation. 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 this product in nursing mothers. Additionally, there are no details regarding whether this product may be present in breast milk or any potential effects it could have on your milk production or your baby.

Given this lack of information, it’s advisable to consult with your healthcare provider before using this product while breastfeeding to ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. If your child swallows this medication, 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 for personalized advice. 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 your treatment, discussing your full medical history and any other medications is essential. This ensures that your healthcare provider can give you the best advice tailored to your needs and help avoid any potential issues. Always feel free to ask questions and share any concerns you may have regarding your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the integrity and effectiveness of the device.

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 comfortzone medicated plantar wart remover used for?

It is used for the removal of plantar warts on the bottom of the foot.

What is the active ingredient in this wart remover?

The active ingredient is salicylic acid, which helps in the removal of plantar warts.

How should I apply the medicated patches?

Wash the affected area, soak the wart in warm water for 5 minutes, dry it thoroughly, and then apply the adhesive side of the patch onto the wart.

How often should I use the patches?

You should repeat the procedure every 48 hours as needed until the wart is removed, for up to 12 weeks.

Are there any contraindications for using this product?

Yes, do not use it if you are diabetic, have poor blood circulation, or on irritated, infected, or reddened skin.

What should I do if I accidentally swallow the product?

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

Is this product safe to use during pregnancy?

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

Can nursing mothers use this product?

There is no specific information provided regarding the use of this product in nursing mothers.

What should I do if discomfort persists after using the product?

If discomfort persists, you should see your doctor or podiatrist.

How should I store this product?

Store it between 59° and 86°F (15° and 30°C).

Packaging Info

Below are the non-prescription pack sizes of Salicylic Acid (medicated plantar wart 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 plantar warts located on the bottom of the foot. Plantar warts are characterized by their specific location, tenderness, and disruption of the footprint pattern.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The affected area should be washed thoroughly, and if desired, the wart may be soaked in warm water for approximately 5 minutes to facilitate treatment. After soaking, the area must be dried completely. If necessary, the medicated patches can be cut to ensure a proper fit over the wart.

The adhesive side of the patch should be applied directly onto the wart. To ensure the patch remains in place and to conceal the area, it is recommended to cover the patch with pads. This procedure should be repeated every 48 hours as needed, continuing until the wart is removed, with a maximum treatment duration of up to 12 weeks.

Contraindications

Use is contraindicated in the following situations:

Patients with diabetes or poor blood circulation should not use this product unless under the advice and supervision of a healthcare professional, such as a doctor or podiatrist, due to the increased risk of complications.

Application is contraindicated on irritated, infected, or reddened skin to prevent exacerbation of these conditions.

The product should not be used on genital warts or warts located on the face, as these areas may require specialized treatment.

It is also contraindicated for use on moles, birthmarks, and warts with hair growing from them, due to the potential for adverse effects.

Additionally, the product must not be applied to mucous membranes, as this may lead to irritation or other complications.

Warnings and Precautions

For external use only. This product is contraindicated in certain populations and conditions.

It should not be used by individuals who are diabetic or have poor blood circulation unless under the guidance and supervision of a qualified healthcare professional, such as a doctor or podiatrist. Additionally, the product must not be applied to irritated, infected, or reddened skin, nor should it be used on genital warts, facial warts, moles, birthmarks, or warts with hair growing from them. Application to mucous membranes is also prohibited.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Patients are advised to discontinue use and consult their healthcare provider if discomfort persists. Regular monitoring and follow-up with a doctor or podiatrist are recommended to ensure safe and effective use of the product.

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, unless used under the advice and supervision of a doctor or podiatrist. The product should not be applied to irritated, infected, or reddened skin, nor should it be used on genital warts, warts on the face, moles, birthmarks, or warts with hair growing from them. Additionally, it should not be applied to mucous membranes.

It is crucial to keep this and all medications out of the reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

If discomfort persists after application, patients are advised to consult their doctor or podiatrist for further evaluation and management.

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 plantar wart 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 and all medications 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.

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

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 evaluation of the benefits versus risks. Women of childbearing potential should be informed of the lack of data and advised to consult their healthcare provider for personalized recommendations.

Lactation

There is no specific information available regarding the use of this product in lactating mothers. Additionally, there are no data concerning the potential for excretion of the product in breast milk or any related considerations for breastfeeding. Healthcare professionals should exercise caution and consider the lack of information when advising lactating mothers.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. Prompt action is essential to ensure the safety and well-being of the patient.

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 the temperature range of 59° to 86°F (15° to 30°C) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's integrity.

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.