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Mirakel Pain Relief Roll-on

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
January 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
January 30, 2024
Manufacturer
Sanvio, Inc.
Registration number
M017
NDC root
78589-257
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

You may find that this medication is designed to temporarily relieve minor pain. It works by targeting the discomfort you may experience, helping to make daily activities more manageable. If you're dealing with minor aches, this drug could be a helpful option for you.

Uses

You can use this medication to temporarily relieve minor pain. Whether you're dealing with a headache, muscle ache, or other types of discomfort, it can help ease your symptoms for a short period. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

Before using the product, make sure to clean the affected area thoroughly. This helps ensure that the medication can work effectively. If you are an adult or a child aged 12 years and older, you can apply the product to the affected area up to 3 to 4 times a day.

If the person needing treatment is under 12 years old, it’s important to consult a doctor before use. This ensures that the medication is safe and appropriate for younger children. Always follow these guidelines to achieve the best results.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

You should be aware that this product is for external use only and is flammable, so keep it away from fire or flames. Avoid using it if you are allergic to lidocaine or other local anesthetics, on large areas of the body, or on broken or irritated skin. It’s also important not to use it on puncture wounds or for more than one week without consulting your doctor.

If you notice that your condition worsens, or if you experience severe burning, redness, rash, or irritation, stop using the product and consult a doctor. Additionally, if your symptoms last longer than seven days or return shortly after improvement, or if you see signs of skin injury like pain, swelling, or blistering at the application site, seek medical advice.

Warnings and Precautions

This product is for external use only and is flammable, so please keep it away from fire or flames. Do not use it if you are allergic to lidocaine or other local anesthetics, on large areas of your body, or on skin that is cut, irritated, blistered, or swollen. Avoid using it on puncture wounds and do not use it for more than one week without consulting your doctor.

If your condition worsens, or if you develop a severe burning sensation, redness, rash, or irritation, stop using the product and contact your doctor. Additionally, if your symptoms last more than seven days or return shortly after clearing up, or if you notice signs of skin injury like pain, swelling, or blistering at the application site, seek medical advice.

In case of accidental swallowing, get emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use for your child.

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 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, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and protect it from light. It's important to keep it away from any fire or flame to prevent hazards. Once you open the product, remember to discard it after use to maintain safety and quality. Following these guidelines will help you handle the product properly and safely.

Additional Information

You should apply the product to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 12 years and older. If your child is under 12 years old, consult a doctor for guidance. Before using the product, make sure to clean the affected area thoroughly. If you are pregnant or breastfeeding, it's important to talk to a health professional before using this product.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor pain.

How should I apply the drug?

Clean the affected area before applying the product. Adults and children 12 years and older can apply it to the affected area not more than 3 to 4 times daily.

What should I do if I am under 12 years old?

If you are under 12 years old, you should ask a doctor before using this product.

Are there any warnings I should be aware of?

Yes, this product is for external use only and is flammable, so keep it away from fire or flame.

When should I stop using the product?

You should stop use and ask a doctor if your condition worsens, if you develop severe burning, redness, rash, or irritation, or if symptoms persist for more than 7 days.

What should I do if I accidentally swallow the product?

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

Is it safe to use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

How should I store this product?

Store at room temperature, protect from light, and keep away from fire or flame. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Mirakel Pain Relief Roll-on (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mirakel Pain Relief Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Mirakel Pain Relief Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is a roll-on formulation designed for topical application. It contains active ingredients that deliver specific therapeutic effects. The formulation includes various inactive ingredients that serve as excipients, contributing to the stability and usability of the product. It is packaged in a roll-on applicator, facilitating ease of use for the user.

Uses and Indications

This drug is indicated for the temporary relief of minor pain. It is suitable for use in patients experiencing mild discomfort due to various conditions.

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 12 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame.

The use of this product is contraindicated in individuals with a known allergy to lidocaine or other local anesthetics. It should not be applied to large areas of the body, nor should it be used on cut, irritated, blistered, or swollen skin. Additionally, it is not recommended for application on puncture wounds. Prolonged use beyond one week should only occur under the guidance of a healthcare professional.

Healthcare providers should advise patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, development of a severe burning sensation, redness, rash, or irritation at the application site, persistence of symptoms beyond seven days, or recurrence of symptoms after resolution within a few days. Signs of skin injury, such as pain, swelling, or blistering at the site of application, also warrant immediate consultation with a healthcare provider.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product may experience a range of adverse reactions. Serious adverse reactions include severe burning sensations, redness, rash, or irritation at the application site. If any of these symptoms develop, patients are advised to stop use and consult a healthcare professional. Additionally, if the condition worsens or symptoms persist for more than seven days, or if they resolve and then recur within a few days, medical advice should be sought.

Common adverse reactions may include localized skin reactions such as irritation or discomfort. Patients should be aware that the product is for external use only and is flammable; therefore, it should be kept away from fire or flame.

Patients should not use this product if they have a known allergy to lidocaine or other local anesthetics. It is also contraindicated for use on large areas of the body, on cut, irritated, blistered, or swollen skin, or on puncture wounds. Furthermore, the product should not be used for more than one week without consulting a doctor.

In the event of signs of skin injury, such as pain, swelling, or blistering at the site of application, patients should discontinue use and seek medical attention.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mirakel Pain Relief Roll-on (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mirakel Pain Relief Roll-on.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 for SPL code 90375-7.

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 prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation. Care should be taken to keep the product away from fire or flame to ensure safety. Once opened, the product should be discarded to avoid any potential risks associated with prolonged exposure to environmental factors.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years, it is recommended to consult a doctor prior to use. Clinicians should counsel patients to clean the affected area before application and to seek advice from a health professional if they are pregnant or breastfeeding. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mirakel Pain Relief Roll-on, 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 Mirakel Pain Relief Roll-on, 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.