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Scholls Wellness Company Llc

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Active ingredient
Salicylic Acid 0.4 g/1 g
Other brand names
Dosage form
Disc
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
December 21, 2025
Active ingredient
Salicylic Acid 0.4 g/1 g
Other brand names
Dosage form
Disc
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
December 21, 2025
Manufacturer
Scholls Wellness Company LLC
Registration number
M030
NDC root
73469-0644

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

Drug Overview

Duragel Callus Remover is a topical treatment specifically designed for the removal of calluses, which are thickened areas of skin that can develop on your feet or hands. This product works by relieving pain associated with calluses as it helps to remove them, making your skin smoother and more comfortable.

If you're dealing with painful or unsightly calluses, Duragel Callus Remover may provide the relief you need by effectively addressing the issue at its source.

Uses

You can use this product to help remove calluses, which are thickened areas of skin that can develop on your feet or hands. By effectively removing these calluses, the product also helps relieve any pain associated with them, making your skin feel smoother and more comfortable.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) associated with this product.

Dosage and Administration

To start treating your callus, first wash the affected area and make sure it is completely dry. If the medicated disc is too large, you can cut it to fit your callus. Once it’s the right size, apply the sticky side of the disc directly onto your skin. After placing the disc, cover it with the cushion that comes with it for added protection.

You should leave the medicated disc on for 48 hours. After this time, carefully remove 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. To help with the removal, you may soak the callus in warm water for about 5 minutes before applying the disc.

What to Avoid

It's important to be cautious when considering this medication. You should not use it if you are diabetic, as it may not be safe for your condition. Additionally, if you have poor blood circulation, this medication is also not suitable for you. Avoid applying it to any irritated skin or areas that are infected or reddened, as this could worsen your situation.

Always prioritize your health and safety by following these guidelines closely. If you have any concerns or questions about your specific health conditions, please consult with your healthcare provider before using this medication.

Side Effects

This product is intended for external use only. If you experience any discomfort that lasts, it’s important to stop using the product and consult a doctor for further advice. Your health and safety are a priority, so don’t hesitate to seek professional guidance if needed.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

You should not use this product if you have diabetes, poor blood circulation, or if you have irritated, infected, or reddened skin. If you experience discomfort that lasts, stop using the product and consult your doctor for further advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, you should call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns outlined in the information provided. This means that the effects of the medication on pregnant individuals and their developing babies are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting any new medication. They can help you understand any potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center. Taking quick action can help ensure their safety. Always be vigilant about where you store medications to prevent any accidents.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20ºC to 25ºC (68º to 77ºF). It's important to keep it away from excessive heat, so avoid exposing it to temperatures above 40ºC (104ºF).

When handling the product, make sure to maintain a clean environment to prevent contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

No further information is available.

FAQ

What is Duragel Callus Remover used for?

Duragel Callus Remover is used for the removal of calluses and relieves pain by removing them.

How should I apply Duragel Callus Remover?

Wash the affected area and dry it thoroughly. If necessary, cut the medicated disc to fit the callus, apply it with the sticky side adhering to the skin, and cover it with the enclosed cushion.

How often can I use Duragel Callus Remover?

You can repeat the procedure every 48 hours as needed for up to 14 days, or until the callus is removed.

Are there any contraindications for using Duragel Callus Remover?

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

What should I do if discomfort lasts after using Duragel Callus Remover?

Stop use and ask a doctor if discomfort lasts.

What precautions should I take when using Duragel Callus Remover?

Keep it out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

What are the storage conditions for Duragel Callus Remover?

Store Duragel Callus Remover between 20ºC to 25ºC (68º to 77ºF) and protect it from excessive heat above 40ºC (104ºF).

Is there any information about using Duragel Callus Remover during pregnancy or lactation?

There are no specific warnings or considerations mentioned regarding pregnancy or nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Scholls Wellness Company Llc (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Scholls Wellness Company Llc.
Details

Drug Information (PDF)

This file contains official product information for Scholls Wellness Company Llc, 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 calluses. It provides relief from pain associated with calluses through effective removal.

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

Dosage and Administration

The affected area should be washed and dried thoroughly prior to application. If necessary, the medicated disc may be cut to fit the size of the callus. The medicated disc should be applied with the sticky side adhering directly to the skin. Following the application, the medicated disc must be covered with the enclosed cushion.

The medicated disc should remain in place for a duration of 48 hours. After this period, the disc should 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 facilitate the removal of the callus, soaking the area in warm water for 5 minutes prior to application is recommended.

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 contraindicated from use, as this may exacerbate their condition and lead to further complications.

Application is not recommended on irritated skin or any area that is infected or reddened, as this may worsen the irritation or infection.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions must be observed to ensure safe usage. This product should not be used by individuals with diabetes or those who have poor blood circulation. Additionally, it is contraindicated for application on irritated skin or any area that is infected or reddened.

Users are advised to discontinue use and consult a healthcare professional if discomfort persists. Monitoring for any adverse reactions is essential to ensure patient safety.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if discomfort persists.

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 Scholls Wellness Company Llc (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Scholls Wellness Company Llc.
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

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding or effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of children who may inadvertently access 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 at a temperature range of 20ºC to 25ºC (68º to 77ºF). Care should be taken to protect the product from excessive heat, specifically temperatures exceeding 40ºC (104ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Scholls Wellness Company Llc, 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 Scholls Wellness Company Llc, 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.