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Miracle Rub

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This product has been discontinued

Active ingredients
  • Menthol 2.5 g/106 g
  • Methyl Salicylate 10 g/106 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
January 12, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 2.5 g/106 g
  • Methyl Salicylate 10 g/106 g
Other brand names
Dosage form
Cream
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 2016
Label revision date
January 12, 2023
Manufacturer
Winning Solutions
Registration number
part348
NDC root
66391-1603
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

Miracle Rub is a topical medication designed to temporarily relieve minor aches and pains in your muscles and joints. It can be particularly helpful for discomfort caused by conditions such as arthritis, simple backaches, strains, sprains, and bruises.

When applied to the skin, Miracle Rub works directly at the site of pain, providing soothing relief to help you feel more comfortable and active. Whether you're dealing with everyday aches or recovering from an injury, this product aims to support your mobility and ease your discomfort.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for discomfort caused by conditions such as arthritis, simple backaches, strains, sprains, and bruises. This means if you're dealing with any of these issues, this medication may help ease your pain and improve your comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

If you are 12 years old or older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure safe and effective use.

If you are caring for a child under 12 years old, it’s important to consult a doctor before using this medication. They can provide the best advice on how to proceed safely.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally ingests it, seek medical help or contact a Poison Control center immediately. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always use it responsibly and as directed.

Side Effects

When using this product, it's important to remember that it is for external use only. This means you should not apply it to your eyes, mouth, or any internal areas.

If you experience any unusual reactions, such as redness, itching, or swelling at the application site, you should stop using the product and consult a healthcare professional. Always prioritize your safety and well-being while using any medication.

Warnings and Precautions

This product is intended for external use only, so please avoid swallowing it. If you accidentally ingest it, seek emergency medical help immediately or contact a Poison Control center for assistance.

Always be cautious when using this product and follow the instructions carefully to ensure your safety. If you experience any unusual reactions or side effects, stop using the product and call your doctor for guidance.

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

There is currently no specific information available about the use of Miracle Rub (menthol, methyl salicylate cream) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation. This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any concerns you may have while breastfeeding.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, you can apply it to the affected area, but be sure to limit the application to no more than 3 to 4 times a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

While there is no specific information about the use of Miracle Rub (menthol, methyl salicylate cream) in older adults, it's always important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can help ensure that it is appropriate for your needs and discuss any potential risks or interactions with other medications you may be taking.

As a caregiver or older adult, staying informed and seeking guidance from a doctor can help you make safe choices regarding pain relief options.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe for your liver health. They can help determine the best approach for your treatment based on your individual circumstances.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have about your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when you're not using it to maintain its integrity. If you open the tube and do not use the contents within a specified time, be sure to discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily if you are an adult or a child aged 12 years and older. If the user is under 12 years old, it’s important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Miracle Rub used for?

Miracle Rub temporarily relieves minor aches and pains of muscles and joints due to conditions like arthritis, simple backache, strains, sprains, and bruises.

How should I use Miracle Rub?

For adults and children 12 years and older, apply to the affected area no more than 3 to 4 times daily. For children under 12 years, ask a doctor before use.

Are there any warnings for using Miracle Rub?

Yes, Miracle Rub is for external use only. Keep it out of reach of children, and in case of accidental ingestion, seek medical help or contact a Poison Control center immediately.

Is Miracle Rub safe to use during pregnancy or while nursing?

The provided information does not mention any specific safety concerns or recommendations regarding the use of Miracle Rub during pregnancy or lactation.

How should I store Miracle Rub?

Store Miracle Rub at room temperature, protect it from light, and keep the tube tightly closed when not in use.

Are there any contraindications for Miracle Rub?

No specific contraindications are listed for Miracle Rub.

Can I use Miracle Rub if I have kidney or liver problems?

The insert does not provide specific information regarding the use of Miracle Rub in patients with kidney or liver problems.

Packaging Info

Below are the non-prescription pack sizes of Miracle Rub (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Miracle Rub.
Details

Drug Information (PDF)

This file contains official product information for Miracle Rub, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

SPL code 34089-3 corresponds to the product labeled as Miracle Rub, available in a 4-ounce (4z) dosage form. The product is identified by the label code 01b LBL_Miracle Rub 4z Rub 0314 OL.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints due to conditions such as arthritis, simple backache, strains, sprains, and bruises.

Limitations of Use: There are no noted teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 12 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the 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.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid ingestion of the product. In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control center for guidance. Prompt action is essential to ensure patient safety and mitigate potential adverse effects.

Side Effects

Patients should be aware that the product is for external use only. Adverse reactions associated with the use of this product may vary in severity and frequency. It is important for patients to monitor for any unexpected effects and report them to their healthcare provider.

In clinical trials, participants were observed for various adverse reactions, although specific data on the frequency and nature of these reactions were not provided. Postmarketing experiences may reveal additional adverse reactions that were not identified during clinical trials.

Patients are encouraged to consult with their healthcare provider for further information regarding potential adverse reactions and to ensure safe and effective use of the product.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Miracle Rub (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Miracle Rub.
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 no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Miracle Rub (menthol, methyl salicylate cream). As there is no available information regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients.

It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the general considerations for increased sensitivity to medications in this age group. Further clinical judgment should guide the use of this product in elderly patients, taking into account their overall health status and any concurrent medications.

Pregnancy

There is no specific information regarding the use of Miracle Rub (menthol, methyl salicylate cream) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. Further studies may be necessary to establish the safety profile of this product in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may not need to take special precautions when prescribing this medication to lactating mothers.

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 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 amount and timing of the substance taken, is crucial for effective treatment 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. It is important to emphasize that in the event of accidental ingestion, patients should seek medical help or contact a Poison Control center immediately. This precaution is vital to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from direct light exposure. To maintain the product's quality, it is essential to keep the tube tightly closed when not in use. Additionally, any unused product should be discarded after opening, adhering to the specified time frame for safe usage.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For patients under 12 years, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Miracle Rub, 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 Miracle Rub, 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.