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Salicylic Acid

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Salicylic Acid 40 mg/4 1
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2003
Label revision date
December 11, 2024
Active ingredient
Salicylic Acid 40 mg/4 1
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 2003
Label revision date
December 11, 2024
Manufacturer
Chain Drug Consortium, LLC
Registration number
M030
NDC root
68016-607

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Drug Overview

Premier Value Medicated Callus Removers is a treatment designed to effectively remove calluses, which are thickened areas of skin that can develop due to pressure and friction. This product contains 40% salicylic acid, a medication that helps to break down and remove the hard skin, providing relief from pain associated with calluses.

The treatment comes with six pads and four medicated patches, making it easy to apply directly to the affected areas. By using this product, you can expect to alleviate discomfort and improve the appearance of your skin.

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.

This treatment is specifically designed for the removal of calluses, making it a targeted solution for your foot care needs. Enjoy the comfort of pain-free feet as you take steps towards healthier skin.

Dosage and Administration

To start using the medicated patch for your callus, first wash the affected area and make sure it is completely dry. If the patch is too large, you can cut it to fit the size of your callus. Once you have the right size, place the adhesive side of the patch directly onto the callus. After applying the patch, cover it with a pad to keep it secure.

You should leave the patch on for 48 hours. After this time, carefully remove it. If needed, 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 patch, as this can help with the removal process.

What to Avoid

You should avoid using this medication if you are diabetic or have poor blood circulation, as it may not be safe for you. Additionally, do not apply it to any irritated skin or areas that are infected or reddened. These precautions are important to ensure your safety and well-being while using this product.

Side Effects

It's important to be aware of some key warnings and precautions when using this product. It is for external use only, so avoid applying it to areas that are irritated, infected, or reddened. If you have diabetes or poor blood circulation, you should not use this product.

If you experience any discomfort that doesn't go away, please consult your doctor or podiatrist. Additionally, keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please do not apply it to any areas that are infected, reddened, or irritated. If you have diabetes or poor blood circulation, you should avoid using this product altogether.

If you experience ongoing discomfort, it’s important to consult your doctor or a podiatrist for further advice. Always keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. 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 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 be aware of certain precautions regarding medication use. You should avoid using this medication if you have diabetes or poor blood circulation, as these conditions can increase the risk of complications. Additionally, do not apply it to any irritated skin or areas that are infected or reddened, as this could worsen your condition or lead to further issues.

Always consult with your healthcare provider before starting any new medication during pregnancy to ensure it is safe for you and your baby. Your health and safety are the top priority, so make sure to discuss any concerns you may have.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the use of this medication while nursing. This means that the effects on breast milk production and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the benefits and risks to ensure the safety of both you and your baby.

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 about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can provide guidance based on your individual needs and kidney function.

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 regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C to 30°C (59°F to 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 sterile field (a clean area free from germs) to prevent 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 Premier Value Medicated Callus Removers used for?

It is used for the removal of calluses and relieves pain by removing them.

What is the active ingredient in Premier Value Medicated Callus Removers?

The active ingredient is Salicylic Acid at a concentration of 40%.

How should I apply the medicated patch?

Wash the affected area and dry it thoroughly, then apply the adhesive side of the medicated patch onto the callus and cover it with a pad.

How long should I leave the medicated patch on?

You should leave the medicated patch on for 48 hours before removing it.

Can I use this product if I have diabetes?

No, you should not use this product if you are diabetic.

What should I do if discomfort persists?

If discomfort persists, you should see your doctor or podiatrist.

Is there any specific information for nursing mothers?

No specific information regarding nursing mothers is provided.

What should I do if the product is swallowed?

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

What are the storage conditions for this product?

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

Are there any contraindications for using this product?

Yes, do not use it on irritated skin, infected areas, or if you have poor blood circulation.

Packaging Info

Below are the non-prescription pack sizes of Salicylic Acid (medicated callus removers). 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 calluses. It provides relief from pain associated with calluses by effectively removing them.

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. If necessary, the medicated patch may be cut to fit the size of the callus. The adhesive side of the medicated patch should be applied directly onto the callus. Following application, the medicated patch must be covered with a pad to ensure proper adherence.

The medicated patch should remain in place for a duration of 48 hours. After this period, the patch must 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 patch 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 also contraindicated, as the product may exacerbate their condition.

Application is not recommended on irritated skin or on any areas that are infected or reddened, as this may lead to further irritation or complications.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with diabetes or those who have poor blood circulation. It should not be applied to irritated skin or any area that is infected or reddened.

Healthcare professionals are advised to instruct patients to seek medical advice if discomfort persists. Consultation with a doctor or podiatrist is recommended in such cases to ensure appropriate management.

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 with a Poison Control Center is advised.

Side Effects

For external use only. Patients should not use this product if they are diabetic, have poor blood circulation, or if applied to irritated skin or any area that is infected or reddened.

In the event that discomfort persists, patients are advised to consult their doctor or podiatrist. It is crucial to keep this product out of reach of children. If swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 (medicated callus removers). 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

Pregnant patients should be advised against the use of this medication if they have diabetes or poor blood circulation, as these conditions may pose additional risks during pregnancy. Furthermore, the medication should not be applied to irritated skin or any areas that are infected or reddened, as this could exacerbate potential adverse effects. The safety of this medication in pregnant women has not been established, and caution is warranted to avoid any potential harm to fetal outcomes. Healthcare professionals should carefully consider these factors when prescribing this medication to women of childbearing potential.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

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

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 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 vital to ensure patient safety and effective recovery.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed that the medication is not suitable for individuals with diabetes or those who have poor blood circulation. It is essential to emphasize that the medication should not be applied to irritated skin or any areas that are infected or reddened.

Additionally, healthcare providers should counsel patients to monitor their condition closely. If discomfort persists after using the medication, patients should be encouraged to consult their doctor or podiatrist for further evaluation and management.

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°C to 30°C (59°F to 86°F) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's integrity during storage and transportation.

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.