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Shoe Pain Relief

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Active ingredient
Lidocaine Hcl 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
March 16, 2026
Active ingredient
Lidocaine Hcl 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
March 16, 2026
Manufacturer
Sole Amie
Registration number
M017
NDC root
87288-001

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Drug Overview

This medication is designed to provide temporary relief from foot pain that may arise from fatigue, minor cuts, scrapes, or skin irritations. It can help soothe discomfort and support your foot health, allowing you to feel more comfortable during your daily activities. If you're experiencing any of these issues, this product may be a helpful option for you.

Uses

If you're experiencing foot pain due to fatigue, minor cuts, scrapes, or skin irritations, this product can provide you with temporary relief. It's designed to help soothe discomfort and support your feet when they need a little extra care.

You can use it to address those everyday issues that can make your feet feel tired or sore, allowing you to stay active and comfortable throughout your day.

Dosage and Administration

To use this medication effectively, start by applying a thin layer to your feet before putting on your shoes. You can also apply it as needed throughout the day. Just remember not to use it more than 3 to 4 times in a single day to ensure safe and effective treatment.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no "do not take" or "do not use" instructions provided, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

When using this product, it's important to remember that it is for external use only and is flammable, so keep it away from fire or flames. Avoid spraying it in your eyes, and be cautious as the contents are under pressure. Do not puncture or incinerate the container, and store it at temperatures below 120°F.

If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. It is flammable, so keep it away from fire or flames. When using this product, be careful not to spray it in your eyes. The contents are under pressure, so do not puncture or incinerate the container, and do not store it at temperatures above 120°F.

If you notice that your condition worsens, or if your symptoms last more than 7 days, or clear up and then come back within a few days, stop using the product and consult your doctor. If the product is swallowed, seek emergency medical help or contact a Poison Control center immediately.

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

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. Due to the lack of safety data, it is not recommended for use in pregnant women. The potential risks to your fetus are unknown, so caution is advised.

Before using this medication, you should consult your healthcare provider to discuss any concerns and to ensure it is safe for you and your baby. There are no specific dosage modifications provided for pregnant women, so professional guidance is essential.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If a child swallows 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 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 without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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, store it in a cool, dry place, avoiding temperatures above 120°F (49°C). This helps maintain its integrity and performance.

Handle the product with care, as it contains contents under pressure. Never puncture or incinerate the device, as this could lead to dangerous situations. Always follow these guidelines to ensure safe usage and storage.

Additional Information

You should apply this product topically by putting a thin layer on your feet before wearing shoes, and you can use it as needed, but no more than 3 to 4 times a day. Remember, this product is for external use only and is flammable, so keep it away from fire or flames.

While using it, avoid spraying it in your eyes, and be cautious as the contents are under pressure—do not puncture or incinerate the container, and do not store it at temperatures above 120°F. If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then come back within a few days, stop using the product and consult your doctor. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control center immediately.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of foot pain associated with fatigue, minor cuts, minor scrapes, and minor skin irritations.

How should I apply this drug?

For adult use, apply a thin layer to your feet before wearing shoes, and as needed. Do not use more than 3 to 4 times daily.

Are there any warnings I should be aware of?

Yes, this product is for external use only and is flammable. Avoid spraying in your eyes, and do not puncture or incinerate the container.

What should I do if I swallow this product?

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

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use in pregnant women due to lack of safety data.

What should I do if my condition worsens or does not improve?

Stop use and ask your doctor if your condition worsens, if symptoms persist for more than 7 days, or if they clear up and reoccur within a few days.

How should I store this product?

Do not store at temperatures above 120°F, and keep out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Shoe Pain Relief (lidocaine hci 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Shoe Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Shoe Pain Relief, 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 temporary relief of foot pain associated with fatigue, minor cuts, minor scrapes, and minor skin irritations.

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

Dosage and Administration

For adult patients, a thin layer of the product should be applied to the feet prior to wearing shoes. This application may be repeated as needed throughout the day. It is important to note that the product should not be used more than 3 to 4 times within a 24-hour period.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame. When using this product, it is imperative to avoid spraying it in the eyes. The contents are under pressure; hence, users should not puncture or incinerate the container. Additionally, it should not be stored at temperatures exceeding 120°F.

In the event of worsening conditions or if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days, users are advised to stop use and consult a healthcare professional.

Emergency medical assistance should be sought immediately if the product is swallowed. Contacting a Poison Control center is also recommended in such cases.

Users should remain vigilant and discontinue use while seeking medical advice if any of the aforementioned conditions arise.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame. When using this product, it is important to avoid spraying it in the eyes. The contents are under pressure, and therefore, users should not puncture or incinerate the container. Additionally, the product should not be stored at temperatures above 120°F.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

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 Shoe Pain Relief (lidocaine hci 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Shoe Pain Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control center should be contacted without delay.

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

Safety during pregnancy has not been established for this medication. It is not recommended for use in pregnant women due to the lack of safety data. The potential risks to the fetus are unknown; therefore, caution is advised when considering this medication for pregnant patients.

No specific dosage modifications for pregnant women are provided. It is essential for women of childbearing potential to consult a healthcare provider before using this medication if they are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control center. This information is vital for ensuring patient safety and prompt intervention if necessary.

Storage and Handling

The product is supplied in containers that are under pressure. It is essential to avoid storing the product at temperatures exceeding 120°F. Care should be taken to ensure that the containers are not punctured or incinerated, as this may compromise the integrity of the product and pose safety risks. Proper handling and storage conditions are crucial to maintain the efficacy and safety of the product.

Additional Clinical Information

The product is intended for topical administration, specifically for adult use. Patients should apply a thin layer to their feet before wearing shoes and may do so as needed, not exceeding 3 to 4 applications daily.

Clinicians should counsel patients on important safety information: the product is for external use only and is flammable, necessitating caution around fire or flame. Patients should avoid contact with eyes and be aware that the contents are under pressure; they should not puncture or incinerate the container and should store it at temperatures not exceeding 120°F. Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control center is recommended.

Drug Information (PDF)

This file contains official product information for Shoe Pain Relief, 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 Shoe Pain Relief, 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.