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Op 6 Menthol Cooling Roll on

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This product has been discontinued

Active ingredient
Menthol 4.2 g/84 g
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
August 2, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 4.2 g/84 g
Other brand names
Dosage form
Liquid
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 2021
Label revision date
August 2, 2021
Manufacturer
RENU LABORATORIES, INC.
Registration number
part348
NDC root
76348-670
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 this medication helpful for the temporary relief of minor aches and pains in your muscles and joints. It is commonly used for conditions such as bruises, sprains, arthritis, and strains, providing you with comfort during recovery. If you're experiencing any of these issues, this drug could be a supportive option to consider.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with various conditions, including bruises, sprains, arthritis, and strains.

You can rely on this treatment to ease your pain and get you back to your daily activities more comfortably. Remember, it's designed for short-term use to help manage those everyday aches.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can apply this medication to the area where you feel pain. You should not apply it more than 10 times a day, and only use it as needed for relief.

If you have a child under 12 years old, it’s important not to use this medication without first consulting a doctor. Always make sure to follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should never bandage the area tightly after application, as this can cause complications. Additionally, make sure to avoid contact with your eyes, and do not apply the medication to any wounds or damaged skin. Using heating pads or other heating devices in conjunction with this medication is also not recommended, as it may lead to unwanted effects.

By following these guidelines, you can help ensure a safer experience with your treatment. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

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, it’s important to stop using the product and consult a doctor. Your health and safety are a priority, so don’t hesitate to seek professional advice if you have concerns.

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 or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. It's important to monitor your health and communicate any concerns with your healthcare provider.

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 always better to be safe and get professional assistance if you think you or someone else may have taken too much of a medication. Remember, timely intervention can be crucial.

Pregnancy Use

Currently, there is no information available about the use of OP 6 Menthol Cooling Roll On 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.

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. 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 your child is under 12 years old, it's important not to use this medication without first consulting a doctor. For children aged 12 and older, you can apply the medication to the affected area, but be sure not to exceed 10 applications in a day, as needed for pain relief. Always follow these guidelines to ensure your child's safety and well-being.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

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

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug provides temporary relief of minor aches and pains of muscles and joints associated with bruises, sprains, arthritis, and strains.

Who can use this drug?

Adults and children 12 years of age and older can apply it to the affected area no more than 10 times a day as needed for pain. Children under 12 years of age should not use it without consulting a doctor.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What should I avoid while using this drug?

You should not bandage tightly, avoid contact with eyes, and do not apply it to wounds or damaged skin. Additionally, do not use it with heating pads or other heating devices.

What should I do if my condition worsens?

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.

What should I do if the drug is swallowed?

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

How should I store this drug?

Store at room temperature, protect from light, keep the container tightly closed, and discard after opening.

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

There is no specific information regarding safety during pregnancy or nursing in the provided text.

Packaging Info

Below are the non-prescription pack sizes of Op 6 Menthol Cooling Roll on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Op 6 Menthol Cooling Roll on.
Details

Drug Information (PDF)

This file contains official product information for Op 6 Menthol Cooling Roll on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product label features images of the packaging, which includes a cooling label and a cooling roll-on label. These images serve to visually represent the product's branding and formulation characteristics.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with bruises, sprains, arthritis, and strains.

There are no 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 10 times per day, as needed for pain relief. It is essential to ensure that the application does not exceed this frequency to avoid potential adverse effects.

For children under 12 years of age, the product is not recommended for use. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance regarding pain management in this age group.

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 adverse reactions.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

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. Monitoring of the patient's condition is essential to ensure appropriate management and to prevent potential complications.

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

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

Packaging & NDC

Below are the non-prescription pack sizes of Op 6 Menthol Cooling Roll on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Op 6 Menthol Cooling Roll on.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For adolescents aged 12 years and older, the recommended application is to the affected area no more than 10 times a day as needed for pain.

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 currently no information available regarding the use of OP 6 MENTHOL COOLING 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 or effects on breastfed infants.

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 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 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 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 this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

While using this product, patients should be cautioned against bandaging tightly and should avoid contact with the eyes. It is important to instruct patients not to apply the product to wounds or damaged skin. Additionally, patients should be advised not to use the product in conjunction with heating pads or other heating devices to prevent adverse effects.

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. The container must be kept tightly closed to protect the contents from light exposure, which can compromise the product's efficacy. Additionally, it is important to discard the product after opening to ensure safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Op 6 Menthol Cooling 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 Op 6 Menthol Cooling 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.