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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
73469-0463

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Drug Overview

Extra Thick Callus Removers are designed specifically for the removal of calluses, which are thickened areas of skin that can develop due to pressure or friction. By using this product, you can effectively relieve pain associated with calluses, making your skin smoother and more comfortable.

This treatment works by targeting and removing the callused skin, helping to restore a more even texture to your feet or hands. If you're dealing with painful calluses, Extra Thick Callus Removers may be a helpful solution for you.

Uses

If you're dealing with calluses, this treatment can help you by effectively removing them. Calluses are thickened areas of skin that can develop due to friction or pressure, and they can be uncomfortable or painful. By using this product, you can relieve that pain and restore smoother skin.

It's important to note that this treatment does not have any known harmful effects on pregnancy (teratogenic effects) or any other non-harmful effects. So, you can feel confident using it as directed.

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. Next, apply the disc with the sticky side facing your skin, and cover it with the cushion that comes with the package.

After 48 hours, you should remove the medicated disc. 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. For better results, you may soak the callus in warm water for about 5 minutes before applying the disc, as this can help with the removal process.

What to Avoid

You should avoid using this product if you are diabetic, as it may not be safe for your condition. Additionally, if you have poor blood circulation, it’s important not to use this product, as it could worsen your situation. Never apply it to irritated skin or any areas that are infected or reddened, as this could lead to further complications. Always prioritize your health and consult with a healthcare professional if you have any concerns.

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. It's important to keep it out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

You should not use this product if you have diabetes or poor blood circulation. Additionally, avoid applying it to any irritated, infected, or reddened skin. If you experience discomfort that lasts, stop using the product and contact 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 help.

In case of an emergency, call your local emergency number 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 considering medication during pregnancy, it's important to be aware that specific safety concerns, dosage modifications, and special precautions are not detailed in the available information. This means that if you are pregnant or planning to become pregnant, you should consult your healthcare provider for personalized advice regarding any medications you may be taking. They can help you understand the potential risks and benefits, ensuring the best care for you and your baby. Always prioritize open communication with your healthcare team about your pregnancy status when discussing treatment options.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation mentioned 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 be crucial in ensuring their safety. Always be vigilant and store medications securely 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 and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you or how it should be managed in the context of liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can help you understand how your liver condition may interact with medications and what steps to take for your health.

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 do so with clean hands and in a safe environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Extra Thick Callus Removers used for?

Extra Thick Callus Removers is used for the removal of calluses and relieves pain by removing them.

How should I use Extra Thick Callus Removers?

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, cover it with the enclosed cushion, and remove it after 48 hours.

How often can I use Extra Thick Callus Removers?

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

Are there any contraindications for using this product?

Do not use Extra Thick Callus Removers 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?

Stop use and ask a doctor if discomfort lasts.

Is Extra Thick Callus Removers safe for children?

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

What are the storage conditions for Extra Thick Callus Removers?

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

Are there any teratogenic effects associated with this product?

No teratogenic effects are mentioned for Extra Thick Callus Removers.

Can I use Extra Thick Callus Removers while pregnant or nursing?

There are no specific warnings or recommendations regarding use during pregnancy or nursing in the provided text.

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 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 assist in 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 potential complications associated with glycemic control.

Individuals with poor blood circulation are advised against use, as it may exacerbate their condition.

Application is contraindicated on irritated skin or any area that is infected or reddened, as this may lead to further irritation or infection.

Warnings and Precautions

For external use only. It is imperative to keep this product 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.

Healthcare professionals should advise patients to discontinue use and consult a physician if discomfort persists. Monitoring for any adverse reactions is essential to ensure patient safety and effective management of any potential complications.

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 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

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the potential benefits and risks when prescribing this medication to women of childbearing potential. It is recommended that patients inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. Further studies may be necessary to fully understand the implications of this medication on pregnancy and fetal development.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been noted in the available information.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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 to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

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, ensuring that temperatures do not exceed 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.

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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.