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Miracle Rub

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This product has been discontinued

Active ingredients
  • Menthol 2.475 g/99 g
  • Methyl Salicylate 9.9 g/99 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 2005
Label revision date
April 5, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 2.475 g/99 g
  • Methyl Salicylate 9.9 g/99 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 2005
Label revision date
April 5, 2011
Manufacturer
Winning Solutions
Registration number
part348
NDC root
66391-0603
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

This medication is 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. By targeting the source of pain, it aims to provide you with relief so you can feel more comfortable in your daily activities.

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 backache, 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

When using this medication, you should apply it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. This helps ensure that you get the best results while minimizing the risk of side effects.

If you are considering using this medication for a child under 12 years old, it’s important to consult with a doctor first. They can provide guidance on the appropriate use and dosage for younger patients. Always follow these instructions carefully to ensure safe and effective treatment.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, you do not need to worry about any particular restrictions or risks related to these issues. Always remember to follow your healthcare provider's guidance for the best outcomes.

Side Effects

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

While side effects are not commonly reported, it's important to be aware of any unusual reactions. If you experience any irritation or discomfort, discontinue use and consult a healthcare professional. Always prioritize your safety and well-being when 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.

It's important to use this product as directed and to be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the effects of the medication on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you weigh the potential risks and benefits to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation 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

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 the medication to the affected area, but be sure not to exceed 3 to 4 applications in 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 available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken.

Always keep in mind that older adults may have different needs when it comes to medication, 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 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 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. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

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 not in use to maintain its integrity. Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these simple 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 a day. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the primary use of this drug?

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

How should I apply this drug?

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

Are there any warnings I should be aware of?

This drug is for external use only. In case of accidental ingestion, seek emergency medical help or contact a Poison Control center immediately.

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

What should I do if I experience side effects?

The provided text does not mention specific side effects, but if you experience any unusual reactions, consult a healthcare professional.

How should I store this drug?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use. Discard after opening.

Is this drug safe to use during pregnancy or while nursing?

The text does not provide specific information regarding safety during pregnancy or nursing, so consult your doctor for personalized advice.

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

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician prior to use.

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. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare providers should instruct patients to contact a Poison Control center or seek emergency medical help without delay.

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.

In clinical trials, participants reported a range of adverse reactions, although specific data on the frequency and seriousness of these reactions were not provided. Postmarketing experiences may also reveal additional adverse reactions that were not observed during clinical trials.

Healthcare professionals are encouraged to monitor patients for any unexpected reactions and report them accordingly.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug 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

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, no information is available concerning the excretion of the drug in breast milk or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this 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 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, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with application to the affected area recommended no more than 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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.