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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
Hudson Health LLC
Registration number
M028
NDC root
72446-015

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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 40% salicylic acid, a medication that helps to dissolve the wart tissue. It comes with 24 medicated patches and 24 concealing pads, allowing you to treat the wart while also protecting and concealing the area.

This no-mess treatment is safe and effective, providing a convenient way to address plantar warts without the need for complicated procedures. If you're dealing with a plantar wart, this product can help you manage the condition while keeping your foot protected.

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 this treatment does not have any known harmful effects on developing babies (teratogenic effects) or any other non-harmful effects.

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 washing, make sure to dry the area completely. If the medicated patch is too large, you can cut it to fit the size of the wart.

Next, carefully place the medicated patch directly over the wart, ensuring it adheres well. To keep the patch in place and to conceal the area, cover it with a pad. You should repeat this process every 48 hours as needed, continuing until the wart is removed, but not exceeding a total of 12 weeks.

What to Avoid

You should avoid using this product if you have irritated, infected, or reddened skin. It is also important not to apply it to genital warts, warts on the face, moles, birthmarks, or warts with hair growing from them. Additionally, do not use it on mucous membranes. If you are diabetic or have poor blood circulation, you should refrain from using this product as well. Following these guidelines will help ensure your safety and well-being.

Side Effects

You should only use this product on unbroken skin, avoiding areas that are irritated, infected, or reddened. It is not suitable for use on genital warts, facial warts, moles, birthmarks, or warts with hair growing from them, and should not be applied to mucous membranes. 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 stop using the product and consult a doctor. Additionally, if the product is 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 any irritated, infected, or reddened skin. It should not be used on genital warts, warts on the face, moles, birthmarks, or warts with hair growing from them. Additionally, if you have diabetes or poor blood circulation, you should not use this product.

If you experience any discomfort that continues, stop using the product and consult your doctor. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for assistance. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to seek immediate medical help. Your safety is the top priority, so getting prompt assistance is crucial.

Pregnancy Use

Currently, there is no information available about the use of Salicylic Acid medicated plantar wart remover patches 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, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no known concerns about the product being passed into breast milk or any associated risks for your infant. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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 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

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 recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication.

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° and 30°C (59° and 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 of any components.

Additional Information

No further information is available.

FAQ

What is comfortzone medicated plantar wart remover?

It is a treatment designed for the removal of plantar warts on the bottom of the foot, containing 40% salicylic acid.

How does comfortzone medicated plantar wart remover work?

It works by providing medicated patches that adhere directly over the wart, helping to remove it while concealing and protecting the area.

What are the instructions for using this product?

Wash the affected area, soak the wart in warm water for 5 minutes, dry thoroughly, and apply the medicated patch. Repeat every 48 hours as needed for up to 12 weeks.

Are there any contraindications for using this product?

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

What should I do if discomfort persists?

You should stop using the product and consult a doctor if discomfort continues.

What should I do if I accidentally swallow the product?

Get medical help or contact a Poison Control Center immediately.

Is this product safe to use during pregnancy or while nursing?

There is no specific information regarding its use during pregnancy or lactation, so consult your doctor before use.

What are the storage conditions for this product?

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

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 specified 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 the disruption of the normal footprint pattern.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The affected area should be washed thoroughly, and if necessary, the wart may be soaked in warm water for approximately 5 minutes to facilitate treatment. After soaking, the area must be dried completely.

If the size of the wart requires it, the medicated patch can be cut to fit the wart appropriately. The medicated patch should then be carefully adhered directly over the wart. To ensure the patch remains in place and to conceal the area, it should be covered with a pad.

This procedure may 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 of this product is contraindicated in the following situations:

  • Application on irritated, infected, or reddened skin is prohibited due to the potential for exacerbating the condition.

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

  • Avoid application on moles, birthmarks, and warts with hair growing from them to prevent adverse reactions.

  • The product is contraindicated for use on mucous membranes, as this may lead to irritation or injury.

  • Individuals with diabetes should not use this product due to the risk of complications associated with skin integrity and healing.

  • Use is contraindicated in patients with poor blood circulation, as this may impair the healing process and increase the risk of adverse effects.

Warnings and Precautions

External use only is mandated for this product. It is imperative that healthcare professionals advise patients against using this product on irritated, infected, or reddened skin. Additionally, it should not be applied to genital warts, facial warts, moles, birthmarks, or warts with hair growing from them. The product is contraindicated for use on mucous membranes.

Patients with diabetes or those exhibiting poor blood circulation should refrain from using this product due to potential complications.

Should discomfort persist following application, it is essential for patients to discontinue use and consult a healthcare provider for further evaluation.

In cases of ingestion, immediate medical assistance is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on irritated, infected, or reddened skin, as well as on genital warts, facial warts, moles, birthmarks, and warts with hair growing from them. Additionally, the product should not be used on mucous membranes, and it is not recommended for individuals with diabetes or poor blood circulation.

In the event that discomfort persists after application, patients are advised to discontinue use and consult a healthcare professional.

It is crucial to note that if the product is swallowed, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

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 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 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 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 plantar wart remover patch 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 are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This 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 a temperature range of 15° to 30°C (59° to 86°F) 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 observed 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.