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Arnicool

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Active ingredient
Menthol 40 mg/1 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 2018
Label revision date
December 26, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 40 mg/1 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 2018
Label revision date
December 26, 2023
Manufacturer
Clinical Resolution Laboratory, Inc.
Registration number
M017
NDC root
63742-007
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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, including those related to arthritis, backaches, strains, and sprains. It is designed to help alleviate discomfort, allowing you to feel more comfortable in your daily activities. If you're experiencing these types of pain, this medication may be a suitable option for you.

Uses

You can use this medication for temporary relief from minor aches and pains. It is effective for sore muscles and joints that may be associated with conditions like arthritis, backaches, strains, and sprains.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects noted with this medication. This makes it a safer option for managing your discomfort without the worry of affecting pregnancy outcomes.

Dosage and Administration

To use this medication effectively, you should apply it generously to the affected area(s) of your skin. Make sure to massage it in thoroughly for about 1 to 2 minutes until it is fully absorbed. For optimal results, it's recommended that you do this 2 to 3 times a day for two weeks. After that initial period, you can continue to use it as needed.

If you are applying this medication for a child under 12 years old, it's important to consult a physician (doctor) first to ensure it's safe and appropriate for their use.

What to Avoid

You should avoid using this product if the Tamper Evident "Do Not Use...Seal..." label on the container is broken. Additionally, if you are pregnant or breastfeeding, it's important to consult a health professional before using this product.

To ensure your safety, do not apply it to your eyes or any mucous membranes, and avoid using it on wounds or damaged skin. It's also best not to combine it with other ointments, creams, sprays, or liniments. If you notice any irritation, refrain from using it on irritated skin, and do not bandage the area or use it with a heating pad or device.

Side Effects

This product is for external use only. You should not use it if the tamper-evident seal is broken or if you are pregnant or breastfeeding without consulting a healthcare professional first. While using this product, avoid contact with your eyes and mucous membranes, and do not apply it to wounds, damaged, or irritated skin. It's important not to use it with other ointments or creams, and you should not bandage the area or use it with heating devices.

If your condition worsens, symptoms persist for more than seven days, or if they clear up and then return, stop using the product and consult a doctor. Always keep this product out of reach of children, and in case of accidental ingestion or overdose, seek medical help immediately.

Warnings and Precautions

This product is for external use only, so please do not apply it to your eyes or ingest it. Before using, make sure the tamper-evident seal on the container is intact. If you are pregnant or breastfeeding, consult a healthcare professional before using this product.

If your condition worsens, symptoms last longer than 7 days, or if they improve and then come back, stop using the product and contact your doctor. Always keep this product out of reach of children. In case of accidental overdose or ingestion, seek immediate help from a doctor or call the Poison Control Center.

Overdose

If you suspect an accidental overdose or have ingested too much of the medication, it’s important to act quickly. Contact your doctor or the Poison Control Center right away for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice any concerning changes in your health, don’t hesitate to seek immediate medical help. Your safety is the top priority, so getting prompt assistance is crucial.

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 receive personalized advice that considers your health and the well-being of your baby. Always prioritize open communication with your doctor to make informed decisions about your care during this time.

Pediatric Use

If your child is under 12 years old, it's important to consult a physician (doctor) before using this product. For children aged 12 and older, you can apply the product generously to the affected area(s) and massage it in thoroughly for 1-2 minutes until it is fully absorbed. For optimal results, it's recommended to apply it 2-3 times a day for two weeks, and then as needed thereafter. Always follow these guidelines to ensure safe and effective use for your child.

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, it’s important to consult with a healthcare provider before starting the medication. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you or how it should be adjusted based on your kidney function.

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

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when using this medication. You should avoid applying it alongside other ointments, creams, sprays, or liniments, as this can lead to unwanted interactions or reduce its effectiveness. Additionally, refrain from using a heating pad or any heating device while using this medication, as heat can affect how the medication works.

Always discuss any medications or treatments you are using with your healthcare provider. They can help ensure that you use this medication safely and effectively, minimizing the risk of interactions.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 59°F and 86°F (15°C to 30°C). This temperature range helps maintain the integrity of the device or product.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You should apply the medication topically to the affected area(s) for the best results. For adults and children aged 12 and older, apply it liberally and massage it in thoroughly for 1-2 minutes until absorbed. It's recommended to use the medication 2-3 times daily for up to 2 weeks, and then as needed. If the patient is under 12 years old, consult a physician before use.

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 arthritis, backache, strains, and sprains.

How should adults and children 12 years and older use this product?

Apply liberally to the affected area(s) and massage thoroughly for 1-2 minutes until absorbed. For best results, use 2-3 times daily for 2 weeks, then as needed.

What should children under 12 do before using this product?

Children under 12 years of age should consult a physician before use.

What precautions should I take when using this product?

Avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin, and do not use with other ointments, creams, sprays, or liniments.

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 recur.

Is this product safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

What should I do in case of accidental overdose or ingestion?

Keep this product out of reach of children and contact a doctor or Poison Control Center immediately if ingested.

What are the storage conditions for this product?

Store the product at room temperature, between 59°F and 86°F.

Packaging Info

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

Packaging configurations for Arnicool.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

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

Dosage and Administration

Adults and children 12 years of age and older should apply the product liberally to the affected area(s) and massage thoroughly for 1 to 2 minutes until fully absorbed. For optimal results, it is recommended to apply the product 2 to 3 times daily for a duration of 2 weeks, after which applications may be made as needed.

For children under 12 years of age, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

  • The Tamper Evident "Do Not Use...Seal..." label atop the container is broken, indicating potential product tampering.

  • Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Additionally, the product should not be applied in the following circumstances:

  • Contact with the eyes or mucous membranes should be avoided.

  • Application to wounds or damaged skin is prohibited.

  • Concurrent use with other ointments, creams, sprays, or liniments is not recommended.

  • The product should not be applied to irritated skin or if excessive irritation develops.

  • Bandaging of the area post-application is not advised.

  • Use with heating pads or devices is contraindicated.

Warnings and Precautions

This product is intended for external use only.

It is imperative that this product not be used if the Tamper Evident "Do Not Use...Seal..." label atop the container is broken. Additionally, pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Users are advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

To ensure safety, this product should be kept out of reach of children. In the event of accidental overdose or ingestion, it is crucial to contact a doctor or the Poison Control Center immediately.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for individuals who are pregnant or breastfeeding unless advised by a health professional. The product should not be used if the Tamper Evident "Do Not Use...Seal..." label atop the container is broken.

When using this product, patients must avoid contact with the eyes or mucous membranes and should not apply it to wounds or damaged skin. It is also advised not to use the product in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin should be avoided, and if excessive irritation develops, use should be discontinued. Bandaging the area after application is not recommended, nor should the product be used with heating pads or devices.

Patients are instructed to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Additionally, the product should be kept out of reach of children. In the event of accidental overdose or ingestion, immediate contact with a doctor or Poison Control Center is essential.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to increased risk of adverse effects or reduced efficacy of the treatment.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The combination may enhance local heat and increase the risk of skin irritation or other adverse reactions.

Monitoring for any signs of irritation or adverse effects is advised when using this medication, particularly in sensitive areas or when considering the use of other topical products or heat sources.

Packaging & NDC

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

Packaging configurations for Arnicool.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents aged 12 years and older, the recommended application involves liberal use on the affected area(s), with thorough massage for 1-2 minutes until fully absorbed. For optimal results, this application should be repeated 2-3 times daily for a duration of 2 weeks, followed by use as needed.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

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

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an accidental overdose or ingestion of the medication, it is imperative to contact a healthcare professional or the Poison Control Center without delay. Prompt medical intervention is crucial to manage potential complications associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific medication involved. Therefore, a thorough assessment of the patient's condition and history is essential for appropriate management.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring of vital signs and clinical status is recommended to ensure patient safety and to address any emergent symptoms that may arise.

In summary, immediate action is required in cases of overdose, emphasizing the importance of contacting medical authorities for guidance and intervention.

Nonclinical Toxicology

Pregnant or breastfeeding individuals are advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to contact a doctor or Poison Control Center immediately in the event of an accidental overdose or if the product is ingested. It is important for patients who are pregnant or breastfeeding to consult a healthcare professional before using this product.

Healthcare providers should instruct patients to monitor their condition closely. If symptoms worsen, persist for more than 7 days, or if symptoms clear up and then recur, patients should seek medical advice.

Patients must be cautioned to avoid contact with the eyes or mucous membranes, as well as to refrain from applying the product to wounds or damaged skin. It is essential to inform patients not to use this product in conjunction with other ointments, creams, sprays, or liniments, and to avoid application on irritated skin or if excessive irritation develops.

Additionally, patients should be advised against bandaging the area after application and should not use the product with a heating pad or any heating device.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 59°F to 86°F (15°C to 30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically. For adults and children aged 12 years and older, it is recommended to apply liberally to the affected area(s) and massage thoroughly for 1-2 minutes until fully absorbed. For optimal results, application should occur 2-3 times daily for a duration of 2 weeks, followed by use as needed. For children under 12 years of age, consultation with a physician is advised.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Arnicool, 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 Arnicool, 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.