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Salicylic Acid

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Active ingredient
Salicylic Acid 0.17 g/7 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
October 27, 2025
Active ingredient
Salicylic Acid 0.17 g/7 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2017
Label revision date
October 27, 2025
Manufacturer
Foodhold USA
Registration number
M028
NDC root
41520-567

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Drug Overview

CAREONE MAXIMUM STRENGTH WART REMOVER GEL is a topical treatment designed to safely remove common and plantar warts. The active ingredient, salicylic acid, works by softening and breaking down the wart tissue, making it easier to remove. Common warts typically have a rough, 'cauliflower-like' appearance, while plantar warts are found on the bottom of the foot and may cause tenderness and disrupt your footprint pattern.

This gel features a convenient, no-drip formula, making it easy to apply. If you're dealing with warts, this product can help you effectively address them in a straightforward manner.

Uses

You can use this medication to help remove common and plantar warts. Common warts are easily identified by their rough, 'cauliflower-like' surface, while plantar warts are found only on the bottom of the foot. These warts can be tender and may disrupt the normal pattern of your footprint.

This treatment is specifically designed to target these types of warts, providing you with a solution to manage and eliminate them effectively.

Dosage and Administration

To start treating your wart, first wash the affected area thoroughly. After cleaning, soak the wart in comfortably warm water for about 5 minutes. This helps to soften the wart, making it easier to treat. Once you've soaked it, dry the area completely.

Next, apply one drop of the gel directly onto the wart, ensuring that it is sufficiently covered. Allow the gel to dry completely before moving on. You should repeat this process once or twice a day until the wart is removed, but do not continue for more than 12 weeks. Following these steps consistently will help you effectively manage the wart.

What to Avoid

You should avoid using this product on certain areas and conditions to ensure your safety. Specifically, do not apply it to moles, birthmarks, or warts that have hair growing from them, as well as mucous membranes like the nose, anus, genitals, and lips. It's also important not to use it on irritated, infected, or reddened skin, or on genital warts and warts located on the face.

If you have diabetes or poor blood circulation, you should refrain from using this product unless you have received guidance and supervision from a doctor or podiatrist. Following these precautions will help prevent potential complications and ensure your well-being.

Side Effects

This product is intended for external use only and should be kept away from fire and flames, as it is flammable. You should avoid using it on moles, birthmarks, warts with hair, mucous membranes (like the nose, anus, genitals, and lips), or on irritated, infected, or reddened skin. It is also not recommended for use on genital warts or facial warts, especially if you have diabetes or poor blood circulation, unless directed by a doctor or podiatrist.

If the product accidentally gets into your eyes, rinse them with water for 15 minutes. Be cautious not to inhale the vapors. Keep this product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center. If you experience ongoing discomfort, please consult your doctor or podiatrist.

Warnings and Precautions

This product is for external use only and should be kept away from fire and flames, as it is flammable. You should not use it on moles, birthmarks, or warts with hair growing from them, nor on mucous membranes (like the nose, anus, genitals, and lips). Avoid applying it to irritated, infected, or reddened skin, as well as genital warts and warts on the face. If you have diabetes or poor blood circulation, consult your doctor or podiatrist before using this product.

While using this product, be careful not to get it in your eyes; if that happens, flush your eyes with water for 15 minutes. Avoid inhaling any vapors. Keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately. If you experience ongoing discomfort, please consult your doctor or podiatrist.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide you with the necessary guidance and support.

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 reach out for help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product has not been evaluated for use during pregnancy. While there are no specific contraindications listed, caution is advised because the safety of salicylic acid (a common ingredient in some products) during pregnancy has not been established. High doses or prolonged use of salicylic acid may pose potential risks to your developing baby.

Before using this product, it is strongly recommended that you consult with your healthcare provider. They can provide personalized advice and help you weigh the benefits and risks based on your individual situation.

Lactation Use

If you are breastfeeding, it's important to know that the safety of this product during lactation has not been established. This means you should be cautious when considering its use while nursing. There is a possibility that the product could be excreted in breast milk, but it is unclear whether salicylic acid (a common ingredient in some medications) could have any effects on breastfed infants.

To ensure the well-being of both you and your baby, it's best to consult with your healthcare provider before using this product while breastfeeding. They can help you weigh the potential risks and benefits based on your specific 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

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 before starting the medication. 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 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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 differently due to your liver health.

Before starting any new medication, including this one, you should discuss your liver condition 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 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 safety and effectiveness of your product, it’s important to store it properly. Keep the product in a cool, dry place, ideally between 59°F to 86°F (15°C to 30°C). Avoid exposing it to fire or flames, as this can pose serious safety risks.

When handling the product, always do so with care to maintain its integrity. Make sure to follow any additional safety guidelines provided with the product to ensure safe usage and disposal.

Additional Information

No further information is available.

FAQ

What is CAREONE MAXIMUM STRENGTH WART REMOVER GEL used for?

It is used for the removal of common and plantar warts.

What is the active ingredient in this wart remover gel?

The active ingredient is salicylic acid.

How should I apply the gel?

After washing and drying the affected area, apply one drop of gel to cover each wart and let it dry. Repeat this once or twice daily for up to 12 weeks.

Are there any contraindications for using this product?

Yes, do not use it on moles, birthmarks, genital warts, or on irritated skin. Consult a doctor if you are diabetic or have poor blood circulation.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so consult a healthcare provider before use.

Can nursing mothers use this product?

Caution is advised as the safety during lactation has not been established, and salicylic acid may be excreted in breast milk.

What should I do if the product gets into my eyes?

If the product gets into your eyes, flush them with water for 15 minutes.

What precautions should I take when using this product?

Keep it away from fire and flame, and out of reach of children. If swallowed, seek medical help immediately.

Packaging Info

Below are the non-prescription pack sizes of Salicylic Acid (wart remover gel). 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.

Uses and Indications

This drug is indicated for the removal of common and plantar warts. Common warts are characterized by their rough, 'cauliflower-like' surface appearance, making them easily recognizable. Plantar warts are specifically located on the bottom of the foot and are identified by their tenderness and the disruption they cause to the footprint pattern.

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

Dosage and Administration

After washing the affected area, the wart should be soaked in comfortably warm water for 5 minutes. Following this, the area must be dried thoroughly. One drop of gel should be applied at a time to ensure sufficient coverage of each wart. The gel should be allowed to dry completely.

This procedure should be repeated once or twice daily 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 moles, birthmarks, and warts with hair growing from them is prohibited due to the potential for adverse effects.

  • The product should not be applied to mucous membranes, including the nose, anus, genitals, and lips, to avoid irritation and complications.

  • It is contraindicated for use on irritated, infected, or reddened skin, as this may exacerbate the condition.

  • The product must not be used on genital warts or warts located on the face to prevent further irritation or complications.

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

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire and flame to prevent any risk of ignition.

The product should not be applied to moles, birthmarks, or warts that have hair growing from them. It is contraindicated for use on mucous membranes, including the nose, anus, genitals, and lips. Additionally, it should not be used on irritated, infected, or reddened skin, nor on genital warts or warts located on the face. Special caution is advised for individuals who are diabetic or have poor blood circulation; use in these cases should only occur under the guidance and supervision of a qualified healthcare professional, such as a doctor or podiatrist.

When using this product, if it comes into contact with the eyes, it is imperative to flush the eyes with water for at least 15 minutes. Users should also avoid inhaling vapors to minimize respiratory irritation.

This product must be kept 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.

If discomfort persists after application, it is advisable to consult a healthcare professional, such as a doctor or podiatrist, for further evaluation and management.

Side Effects

Patients should be aware that this product is for external use only and is flammable; it should be kept away from fire and flame. The product should not be used on moles, birthmarks, or warts with hair growing from them, nor should it be applied to mucous membranes such as the nose, anus, genitals, and lips. Additionally, it is contraindicated for use on irritated, infected, or reddened skin, as well as on genital warts and warts on the face.

Patients with diabetes or poor blood circulation should only use this product under the advice and supervision of a doctor or podiatrist. During use, if the product comes into contact with the eyes, it is important to flush the eyes with water for 15 minutes. Patients should also avoid inhaling vapors associated with the product.

This product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical help or contact a Poison Control Center immediately. If discomfort persists after use, 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 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 (wart remover gel). 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 the Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information 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 product has not been evaluated for safety in pregnancy. Caution is advised, as the safety of salicylic acid during pregnancy is not established. While specific potential risks to the fetus are not detailed, salicylic acid is known to be associated with risks when used in high doses or for prolonged periods during pregnancy. No specific dosage modifications for pregnant individuals are provided. It is recommended that pregnant patients consult a healthcare provider before use.

Lactation

The safety of this product during lactation has not been established. Caution should be exercised when using this product in nursing mothers.

There is a potential for excretion in breast milk. It is not known whether salicylic acid can affect breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 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. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 that if the medication is swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately. This information is vital for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in configurations that adhere to the specified NDC numbers. It is essential to store the product in a controlled environment, maintaining a temperature range between 59°F to 86°F (15°C to 30°C).

Care should be taken to keep the product away from fire and flame to ensure safety and integrity. Proper storage conditions are crucial for maintaining the quality and efficacy of the product.

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.