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Avcoo Pain Relief Roll on

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Active ingredients
  • Menthol 10 g/100 mL
  • Methyl Salicylate 20 g/100 mL
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 2025
Label revision date
February 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 mL
  • Methyl Salicylate 20 g/100 mL
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 2025
Label revision date
February 19, 2025
Manufacturer
ADP Health Limited
Registration number
M017
NDC root
84992-002
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 can use this medication for temporary relief from minor aches and pains associated with sore muscles and joints. It is particularly helpful for conditions like simple backaches, arthritis, strains, bruises, and sprains. This means that if you're experiencing discomfort from these common issues, this drug may provide you with some much-needed relief.

Uses

You can use this medication for temporary relief from minor aches and pains in your muscles and joints. It is effective for conditions such as simple backaches, arthritis, strains, bruises, and sprains. This means if you're dealing with discomfort from 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

To use this medication, apply a thin film directly to the affected area of your skin. You should do this no more than 3 to 4 times a day. After applying the medication, make sure to wash your hands with cold water to avoid spreading it to other areas or surfaces.

If you are considering this treatment for a child under 12 years old, it’s important to consult a doctor first. This ensures that the medication is safe and appropriate for their use.

What to Avoid

You should avoid using this product if you are allergic to any of its ingredients. It's also important not to use it in combination with a heating pad, as this can lead to unwanted effects. Additionally, do not apply the product to mucous membranes or on areas of your skin that are cut, broken, swollen, or irritated, as this could cause further irritation or complications.

Remember, using this product improperly can lead to issues such as dependence (a condition where your body becomes reliant on a substance) or misuse, so it's crucial to follow these guidelines closely for your safety.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if you notice any worsening of your skin condition, such as increased redness, irritation, swelling, or blistering. If your symptoms last longer than seven days or return shortly after improving, seek medical advice.

Additionally, be cautious if you have sensitive skin, as this product may cause irritation. Always avoid contact with your eyes, and remember that this product is for external use only. It is flammable, so keep it away from heat and open flames, and do not heat or microwave it.

Warnings and Precautions

Please read all directions and warnings carefully and use this product only as directed. Remember, it is for external use only and is flammable, so keep it away from heat and open flames. Avoid heating or microwaving the product, and do not add it to hot water, as this can cause splattering and burns. When applying, do not squeeze the bottle, and be cautious if you have sensitive skin. Always keep the product out of reach of children and pets; if swallowed, seek medical help or contact a Poison Control Center immediately.

If you notice any signs of skin injury or worsening conditions, such as redness, irritation, swelling, or blistering, stop using the product and call your doctor. Additionally, if your symptoms persist for more than 7 days or improve and then return within a few days, it’s important to consult your healthcare provider.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific details about overdose symptoms or treatment in the available information, general signs of an overdose can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or have concerns about an overdose, seek medical help right away.

In case of an overdose, contacting a healthcare professional or poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution and reach out for help if you feel something is wrong. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. If your child is younger than this age, please consult a doctor for advice on appropriate treatment options. Always prioritize your child's safety and well-being by seeking professional guidance when it comes to their health.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to be cautious when using certain medications or treatments. For instance, you should avoid using a heating pad while taking this medication, as it can lead to unwanted effects. Always discuss any medications you are taking with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Additionally, there are no specific laboratory test interactions noted, but it's still a good practice to inform your healthcare provider about all the medications you are using. This way, they can provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a dry place at room temperature, ideally between 20-25°C (77-86°F). It's important to keep it away from direct sunlight, as exposure can affect its quality.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically by rubbing a thin film over the affected area no more than 3-4 times a day. If you have sensitive skin, use it with caution. It's important to consult a healthcare professional if you are pregnant or breastfeeding before using this product.

Be sure to stop using the medication and contact a doctor if you notice any worsening of your condition or signs of skin injury, such as redness, irritation, swelling, or blistering. If your symptoms do not improve after 7 days or if they clear up and then return within a few days, seek medical advice.

FAQ

What is the primary use of this drug?

This drug provides temporary relief from minor aches and pains of sore muscles and joints associated with conditions like simple backaches, arthritis, strains, bruises, and sprains.

How should I apply this drug?

You should rub a thin film over the affected area no more than 3-4 times daily and wash your hands with cold water after use.

Are there any age restrictions for using this drug?

Do not use this drug on children under 12 years of age without consulting a doctor.

What should I do if I experience skin irritation?

Stop use and call your doctor if you notice any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering.

Are there any contraindications for this drug?

Do not use this drug if you are allergic to any of the listed ingredients, with a heating pad, or on mucous membranes, cuts, broken, swollen, or irritated skin.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare professional before using this drug.

What precautions should I take while using this drug?

This drug is for external use only and is flammable. Keep it away from excessive heat and open flames, and avoid contact with eyes.

What should I do if my symptoms persist?

If your condition worsens or symptoms persist for more than 7 days, or if they clear up and occur again within a few days, stop use and consult your doctor.

How should I store this drug?

Store the drug in a dry place at room temperature between 20-25°C (77-86°F) and away from direct sunlight.

Packaging Info

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

Packaging configurations for Avcoo Pain Relief Roll on.
Details

Drug Information (PDF)

This file contains official product information for Avcoo Pain Relief Roll on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as simple backaches, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

The recommended application involves rubbing a thin film of the product over the affected area no more than 3 to 4 times daily. It is essential for healthcare professionals to advise patients to wash their hands thoroughly with cold water after each use to prevent unintentional contact with other areas of the body or with other individuals.

For pediatric patients, it is important to note that the product is not recommended for use in children under 12 years of age without prior consultation with a healthcare provider.

Contraindications

Use is contraindicated in individuals with a known allergy to any of the listed ingredients. Application with a heating pad is also contraindicated due to the potential for increased risk of adverse effects. Additionally, the product should not be applied to mucous membranes, or on areas of the skin that are cut, broken, swollen, or irritated, as this may exacerbate the condition or lead to further complications.

Warnings and Precautions

It is imperative that all directions and warnings are thoroughly reviewed and that the product is used strictly as directed. This product is intended for external use only.

Flammability and Heating Precautions The product is flammable; therefore, it must be kept away from excessive heat and open flames. It is crucial to avoid heating or microwaving the product. Additionally, it should not be added to hot water or any container with heated water, as this may lead to splattering and potential burns.

Application Guidelines When applying the product, it is important not to bandage tightly and to avoid contact with the eyes. For individuals with sensitive skin, caution is advised during use. Furthermore, the bottle should not be squeezed during application to prevent excessive product release.

Child and Pet Safety This product should be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Monitoring and Medical Consultation Users are advised to discontinue use and consult a healthcare professional if any signs of deterioration or skin injury occur, including but not limited to redness, irritation, swelling, or blistering. Additionally, if the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, medical advice should be sought promptly.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat and open flames. It is crucial not to heat or microwave the product, nor should it be added to hot water or any container with heated water, as this may cause splattering and result in burns. Additionally, patients are advised not to bandage the area tightly and to avoid contact with the eyes. For individuals with sensitive skin, caution is recommended during use. It is also important to avoid squeezing the bottle during application to prevent unintended release of the product.

Patients should discontinue use and consult a doctor if they experience any signs of deterioration or skin injury, which may include redness, irritation, swelling, or blistering. If the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, medical advice should be sought.

Drug Interactions

The use of this medication is contraindicated with heating pads due to the potential for increased risk of adverse effects. It is advised that patients refrain from using heating pads while on this medication to avoid any complications.

There are no specific laboratory test interactions associated with this medication, indicating that it does not interfere with standard laboratory assessments. Therefore, routine monitoring through laboratory tests can proceed without modification.

Packaging & NDC

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

Packaging configurations for Avcoo Pain Relief Roll on.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. The safety and efficacy of this treatment have not been established in this age group, and appropriate dosing guidelines are not available. It is essential for healthcare providers to evaluate the risks and benefits before prescribing this medication to pediatric patients.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Healthcare professionals should monitor patients closely for any potential symptoms that may arise from an overdose. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of an overdosage, it is recommended that healthcare providers initiate supportive care, which may include the following steps:

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

  2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's needs.

  3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the situation.

Due to the lack of specific overdosage information, it is imperative for healthcare professionals to remain vigilant and utilize their clinical judgment in managing any cases of suspected overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, individuals are advised to consult a healthcare professional prior to use. There are no specific non-teratogenic effects or detailed nonclinical toxicology findings available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

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 and pets to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This precaution is essential to ensure the safety of both children and pets in the household.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a dry environment, maintaining a temperature range of 20-25°C (77-86°F). Care should be taken to keep the product away from direct sunlight to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommendation to apply a thin film over the affected area no more than 3-4 times daily. Clinicians should advise patients with sensitive skin to use the product with caution. Pregnant or breastfeeding patients are encouraged to consult a healthcare professional prior to use.

Patients should be instructed to discontinue use and seek medical advice if they notice any signs of deterioration or skin injury, including redness, irritation, swelling, or blistering. Additionally, if the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients should contact their healthcare provider.

Drug Information (PDF)

This file contains official product information for Avcoo Pain Relief 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 Avcoo Pain Relief 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

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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.