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Salicylic Acid

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Active ingredient
Salicylic Acid 0.17 mg/9.8 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
October 8, 2025
Active ingredient
Salicylic Acid 0.17 mg/9.8 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
October 8, 2025
Manufacturer
Hudson Health LLC
Registration number
M030
NDC root
72446-010

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Drug Overview

Comfortzone is a liquid corn and callus remover designed to safely eliminate corns and calluses, which are thickened areas of skin that can cause discomfort. It contains salicylic acid, a common ingredient that helps to break down the hard skin, providing relief from pain associated with these conditions.

In addition to its active ingredient, Comfortzone comes with soft foam cushions that protect the surrounding skin while you treat the affected areas. This product is available in a 0.33 FL OZ (9.8 mL) bottle, making it easy to use at home for effective foot care.

Uses

If you're dealing with corns and calluses, this treatment can help you by effectively removing them. Not only does it assist in getting rid of these skin issues, but it also provides relief from the pain they can cause. By addressing both the physical presence of corns and calluses and the discomfort they bring, you can find a solution that improves your foot health and comfort.

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 daily, as necessary, for up to 14 days, or until the corn or callus is completely removed.

What to Avoid

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

Side Effects

This product is for external use only and should be kept away from fire or flames, as it is flammable. Make sure to store it at room temperature and tightly cap the bottle. Avoid using it on irritated or infected skin, and if you have diabetes or poor blood circulation, consult your doctor or podiatrist before use.

While using this product, be careful to avoid contact with your eyes and do not inhale the vapors. If the product does get into your eyes, rinse them with water for 15 minutes. If you experience ongoing discomfort, please consult your doctor or podiatrist. Keep this product out of reach of children, and 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 any irritated or infected skin. If you have diabetes or poor blood circulation, consult your doctor or podiatrist before using it. Remember to 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 not to let it come into contact with your eyes or to inhale the vapors. If it accidentally gets into your eyes, rinse them with water for 15 minutes. If you experience ongoing discomfort, stop using the product and consult your doctor or podiatrist. Always keep this product out of reach of children, and if it is 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 symptoms that require prompt attention.

Always err on the side of caution—if you suspect an overdose, don’t wait for symptoms to appear. Getting help quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with the use of salicylic acid, as there is no specific information available about its safety during pregnancy. This means that the potential risks, dosage adjustments, or any special precautions related to its use while pregnant have not been clearly established.

Before using any products containing salicylic acid, you should consult with your healthcare provider to discuss your individual situation and any concerns you may have. Your health and the health of your baby are the top priority, so it's best to seek professional advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of this medication during lactation (the period of breastfeeding). This means that the effects on breast milk production or the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider for personalized advice and to discuss any concerns you may have about medications while breastfeeding. They can help you weigh the benefits and risks based on your individual 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

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

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 available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your liver health. They can provide guidance based on your individual situation.

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 to 30°C (68°F to 86°F). Make sure to keep it away from any sources of heat, fire, or flame to prevent any hazards.

When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is Comfortzone?

Comfortzone is a liquid corn and callus remover that safely removes corns and calluses while relieving pain.

What is the active ingredient in Comfortzone?

Comfortzone contains salicylic acid, which helps in the removal of corns and calluses.

How should I use Comfortzone?

Wash the affected area and dry it thoroughly. Apply one drop at a time with the applicator to cover each corn or callus, and let it dry. Use the provided cushions to relieve pressure.

How often can I use Comfortzone?

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

Are there any contraindications for using Comfortzone?

Do not use Comfortzone on irritated skin, infected or reddened areas, or if you are diabetic or have poor blood circulation without a doctor's supervision.

What precautions should I take when using Comfortzone?

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

What should I do if discomfort persists?

If discomfort persists, stop using the product and consult your doctor or podiatrist.

Is Comfortzone safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Comfortzone during pregnancy or nursing.

How should I store Comfortzone?

Store Comfortzone at room temperature, away from heat, and keep the bottle tightly capped.

What should I do if Comfortzone is swallowed?

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

Packaging Info

Below are the non-prescription pack sizes of Salicylic Acid (corn and callus remover kit). 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 mentioned in the available data.

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 treated area, it is recommended to use cushions with a hole centered over the corn or callus. 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:

The product should not be applied to irritated skin, as this may exacerbate the condition. Additionally, it is contraindicated for use on any area that is infected or reddened, due to the risk of worsening the infection or irritation.

Patients with diabetes or poor blood circulation should avoid use unless under the advice and supervision of a qualified healthcare professional, such as a doctor or podiatrist, due to potential complications associated with these conditions.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from fire or flame. The bottle must be capped tightly and stored at room temperature, away from heat sources.

The product should not be applied to irritated skin or any area that is infected or reddened. Additionally, individuals with diabetes or poor blood circulation should refrain from using this product unless advised and supervised by 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 recommended to flush the eyes with water for at least 15 minutes.

If discomfort persists after application, the user should discontinue use and consult a healthcare provider. It is essential to keep this product out of reach of children. In case of accidental ingestion, 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 flammable; therefore, it is essential to keep it away from fire or flame. The bottle should be capped tightly and stored at room temperature, away from heat sources.

The product should not be used on irritated skin or on any area that is infected or reddened. Additionally, individuals who are diabetic or have poor blood circulation should only use this product under the advice and supervision of a doctor or podiatrist.

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

Patients are advised to stop using the product and consult a doctor if discomfort persists. It is also important to keep this product out of reach of children. If swallowed, medical help should be sought immediately, or contact a Poison Control Center right away.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 (corn and callus remover kit). 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 available 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

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 specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, no data are provided concerning the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

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 the use of this medication. Consequently, there is no information available 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.

Overdosage

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

Prompt intervention 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, 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 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 healthcare professional, such as a doctor or podiatrist.

Healthcare providers should counsel patients to discontinue use and consult a doctor if discomfort persists. Additionally, patients should be made aware to avoid contact with the eyes and to refrain from inhaling vapors while using the product. In case of accidental contact with the eyes, patients should flush the eyes with water for at least 15 minutes and seek medical attention if necessary.

Storage and Handling

The product is supplied in a tightly capped bottle. It is essential to store the bottle at room temperature, ensuring it is kept away from heat sources. The recommended storage temperature range is between 20°C to 30°C (68°F to 86°F). Additionally, it is crucial to keep the product away from fire or flame to maintain safety and 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.