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Sugarloaf Organics Menthol Revive

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Active ingredient
Menthol 5.9 g/118 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
August 21, 2025
Active ingredient
Menthol 5.9 g/118 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
August 21, 2025
Manufacturer
RENU LABORATORIES, LLC
Registration number
M017
NDC root
76348-996

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Drug Overview

Sugarloaf Organics Revive Menthol Pain Cream is a topical product designed to provide temporary relief from minor aches and pains. It can be used for various conditions, including arthritis, simple backache, muscle strains, sprains, and bruises. The cream contains menthol, which helps to soothe discomfort by creating a cooling sensation on the skin, making it easier for you to manage pain in your daily activities.

Uses

If you're dealing with minor aches and pains, this medication can help provide temporary relief. It's effective for discomfort related to various conditions, including arthritis, simple backaches, muscle strains, sprains, and bruises.

You can rely on this treatment to ease your pain and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of discomfort.

Dosage and Administration

To use this medication, start by applying it directly to your skin. Make sure to massage it in gently until it is completely absorbed. You can repeat this process as needed, depending on your comfort and the guidance provided by your healthcare professional.

It's important to store the medication at room temperature, away from extreme heat or cold, to ensure it remains effective. Always follow these steps to get the best results from your treatment.

What to Avoid

It's important to follow specific guidelines when using this product to ensure your safety. You should avoid bandaging tightly, as this can cause complications. Additionally, keep the product away from your eyes and do not apply it to any wounds or damaged skin, as this could lead to irritation or other issues.

Furthermore, refrain from using this product in conjunction with heating pads or other heating devices, as this may increase the risk of adverse effects. By adhering to these instructions, you can help ensure a safe and effective experience.

Side Effects

This product is intended for external use only. If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor. It's important to monitor your symptoms closely to ensure your safety and well-being.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. Keep it out of reach of children, and if it is swallowed, seek medical help immediately or contact a Poison Control Center.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Your health and safety are important, so don’t hesitate to reach out for help if you have any concerns.

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 or symptoms of an overdose for this medication, general signs can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room for assistance. Always keep medications out of reach and follow the prescribed dosage to prevent any risks.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it is essential to discuss any medications you are considering with your healthcare provider. They can help you understand the implications and make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the information available does not include specific guidelines or considerations for nursing mothers or lactation (the process of producing milk). This means that there are no detailed recommendations or warnings regarding the use of certain medications or substances while you are nursing.

Always consult with your healthcare provider for personalized advice and to discuss any concerns you may have about breastfeeding and the safety of medications or treatments you may be considering. Your healthcare provider can help ensure that both you and your baby remain healthy during this important time.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of 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

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, 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 your medication dosage may need to be adjusted. This is particularly true if your kidneys are not functioning as well as they should be. Regular monitoring of your renal function tests is essential to ensure your kidneys are managing medications effectively.

If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should consider a reduced dose of your medication. Always consult with your healthcare provider to determine the best approach for your specific situation.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

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 results, store the product at room temperature. When using it, gently massage the product into your skin until it is fully absorbed. You can repeat this process as needed for optimal effectiveness. Following these simple steps will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Sugarloaf Organics Revive Menthol Pain Cream used for?

It is used for temporary relief of minor aches and pains associated with arthritis, simple backache, muscle strains, sprains, and bruises.

How should I apply the pain cream?

Massage the cream into the skin until thoroughly absorbed and repeat as needed.

Are there any contraindications for using this cream?

No specific contraindications are mentioned for Sugarloaf Organics Revive Menthol Pain Cream.

What precautions should I take when using this cream?

Avoid bandaging tightly, contact with eyes, applying to wounds or damaged skin, and using with heating pads or other heating devices.

What should I do if my condition worsens or symptoms persist?

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

Is this cream safe for use during pregnancy or while nursing?

No specific information regarding safety during pregnancy or nursing is provided in the insert.

What should I do if I accidentally swallow the cream?

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

How should I store Sugarloaf Organics Revive Menthol Pain Cream?

Store the cream at room temperature.

Are there any known drug interactions with this cream?

No specific drug interactions are mentioned for this product.

What are the warnings associated with this cream?

The cream is for external use only, and you should keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Sugarloaf Organics Menthol Revive (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sugarloaf Organics Menthol Revive.
Details

Drug Information (PDF)

This file contains official product information for Sugarloaf Organics Menthol Revive, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals are advised to massage the product into the skin until it is thoroughly absorbed. This application may be repeated as needed based on the patient's condition and response to treatment. It is important to store the product at room temperature to maintain its efficacy and stability.

Contraindications

Use of this product is contraindicated in the following situations:

  • Tight bandaging should be avoided to prevent compromised circulation.

  • Contact with the eyes must be avoided to prevent irritation or injury.

  • Application to wounds or damaged skin is contraindicated due to the risk of adverse effects.

  • Concurrent use with heating pads or other heating devices is not recommended, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

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 Sugarloaf Organics Menthol Revive (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sugarloaf Organics Menthol Revive.
Details

Pediatric Use

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

Geriatric Use

There is no specific information 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, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this drug 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 on this medication.

Lactation

There are no specific statements or considerations regarding nursing mothers or lactation provided in the prescribing information. Therefore, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the absence of data necessitates careful consideration of the potential risks and benefits.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a configuration that allows for easy application. It should be stored at room temperature to maintain its efficacy. For optimal results, the product should be massaged into the skin until thoroughly absorbed. This process can be repeated as needed to achieve the desired effect. Special handling requirements are not specified; however, care should be taken to ensure the product is kept in a suitable environment to preserve its quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sugarloaf Organics Menthol Revive, 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 Sugarloaf Organics Menthol Revive, 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.