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Miracle of Aloe Rub Roll on

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This product has been discontinued

Active ingredient
Menthol 1.8 mL/90 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2006
Label revision date
April 4, 2011
Active ingredient
Menthol 1.8 mL/90 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2006
Label revision date
April 4, 2011
Manufacturer
Winning Solutions
Registration number
part348
NDC root
66391-0046

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can be particularly effective for discomfort caused by conditions such as arthritis, simple backaches, strains, and sprains. If you're experiencing any of these types of pain, this drug may help provide you with some relief.

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, and sprains.

This means that if you're dealing with soreness from these issues, this medication can help ease your pain and improve your comfort. Always consult with a healthcare professional if you have any questions about your specific situation or how to use this medication effectively.

Dosage and Administration

If you or your child is 3 years old or older and need to use this medication, you should apply it to the affected area no more than 3 to 4 times each day. This helps ensure that you get the best results while minimizing any potential side effects.

If your child is under 3 years old, it’s important to consult with a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children. Always follow these instructions carefully to ensure safe and effective use.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications (conditions that would prevent you from taking it) or controlled substance classifications associated with it. Additionally, there are no known risks of abuse, misuse, or dependence (a condition where your body becomes reliant on a substance) linked to this medication.

Since there are no specific "do not take" or "do not use" instructions, you can proceed with its use as directed by your healthcare provider. Always consult with them if you have any questions or concerns about your treatment.

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.

If you experience any unusual reactions, such as redness, itching, or swelling at the application site, it’s important to 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.

It's important to be cautious while using this product. If you experience any unusual reactions or side effects, stop using it and call your doctor for guidance. Always prioritize your health and safety when using any medication or treatment.

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 considering the use of MIRACLE OF ALOE RUB ROLL ON during pregnancy, it's important to note that there is no information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products. They can help you make informed decisions based on your specific health needs and circumstances.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned 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. Always consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

When using this medication for children aged 3 years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 3 years old, it's important to consult a doctor before use. This ensures that the treatment is safe and appropriate for their age. Always follow these guidelines to help keep your child safe and healthy.

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 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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 interactions with other drugs or laboratory tests. 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 tests during your appointments.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature in a cool, dry place. It's important to keep the container tightly closed to prevent contamination and maintain its effectiveness. Additionally, protect the product from light exposure, as this can affect its stability. Once you open the container, be sure to discard any unused product to avoid potential risks. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication topically to the affected area, using it no more than 3 to 4 times a day. This means you can put it directly on the skin where you need treatment, but be careful not to exceed the recommended frequency. If you have any questions about how to use the medication or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is the general use of this drug?

This drug temporarily relieves minor aches and pains of muscles and joints.

What conditions does this drug relieve?

It relieves aches and pains due to arthritis, simple backache, strains, and sprains.

Who can use this drug?

Adults and children 3 years and older can use it; for children under 3 years, you should ask a doctor.

How often can I apply this drug?

You can apply it to the affected area no more than 3 to 4 times daily.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

Is this drug safe for nursing mothers?

There are no specific warnings or considerations mentioned regarding nursing mothers.

What should I do in case of accidental ingestion?

Get emergency medical help or contact a Poison Control center right away.

How should I store this drug?

Store it at room temperature, keep the container tightly closed, and protect it from light.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is this drug a controlled substance?

No controlled substance classification or details are provided.

Packaging Info

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

Packaging configurations for Miracle of Aloe Rub Roll on.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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, and sprains.

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

Dosage and Administration

For adults and children aged 3 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. It is advised that individuals under the age of 3 years 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 intended 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 effects and to report any adverse reactions to the appropriate regulatory authorities.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Miracle of Aloe Rub Roll on.
Details

Pediatric Use

Pediatric patients aged 3 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 3 years of age, it is advised to consult a physician before use.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of MIRACLE OF ALOE RUB ROLL ON during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. Further monitoring of breastfed infants may be warranted, although no adverse effects have been documented in the available data.

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, 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 toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

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 of Aloe Rub 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 Miracle of Aloe Rub 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.

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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.