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Eagle Brand

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Active ingredients
  • Menthol 14.5 g/100 mL
  • Methyl Salicylate 30 g/100 mL
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 2015
Label revision date
July 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 14.5 g/100 mL
  • Methyl Salicylate 30 g/100 mL
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 2015
Label revision date
July 15, 2025
Manufacturer
Borden Company (Private) Limited
Registration number
M017
NDC root
43405-011
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

This medication is designed to provide temporary relief from minor aches and pains in muscles and joints. It can be helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from any of these issues, this product may offer you some relief.

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 various conditions, including simple backaches, arthritis, strains, bruises, and sprains.

You can rely on this treatment to ease discomfort and help you get back to your daily activities. Remember, it's designed for short-term use to alleviate those nagging pains that can disrupt your routine.

Dosage and Administration

If you are 12 years old or older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure safe and effective use.

If you are caring for a child under 12 years of age, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger patients.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should never apply it to wounds or damaged skin, as this can lead to complications. Additionally, avoid bandaging the area tightly, as this may interfere with the medication's effectiveness. Always follow the directions provided and do not use the medication in any way other than as instructed.

By adhering to these guidelines, you can help ensure that you use the medication safely and effectively. If you have any questions or concerns about its use, please consult your healthcare provider.

Side Effects

This product is for external use only, so be sure to avoid contact with your eyes or mucous membranes. It's important not to apply it to wounds or damaged skin, and you should avoid tightly bandaging the area. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Centre immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any mucous membranes. It's important not to use it on wounds or damaged skin, and you should avoid tightly bandaging the area after application. Always follow the directions provided and do not use the product in any other way.

If your condition worsens, or if your symptoms last longer than 7 days or return shortly after improvement, stop using the product and consult your doctor. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Centre immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Centre or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby 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 doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 12 years old, it's important not to use this medication without first consulting a doctor. For those aged 12 and older, you can apply the medication to the affected area, but be sure to limit it to no more than 3 to 4 times a day. Always follow these guidelines to ensure the safety and well-being of 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 for personalized advice. 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 if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool place, keeping the temperature below 86°F (30°C). This helps maintain its effectiveness and integrity.

When handling the product, always do so with care to avoid any damage. Make sure to follow any specific instructions provided for use and disposal to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is this product used for?

This product is used for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Who can use this product?

Adults and children 12 years of age and older can use this product. Children under 12 years of age should not use it without consulting a doctor.

How should I apply this product?

You should apply it to the affected area not more than 3 to 4 times daily.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid getting it into your eyes or mucous membranes, and do not apply it to wounds or damaged skin.

What should I do if my condition worsens?

If your condition worsens or if symptoms persist for more than 7 days, discontinue use and consult a doctor.

What should I do if I swallow this product?

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

Can I use this product if I am pregnant or breastfeeding?

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

How should I store this product?

Store this product below 86°F (30°C).

Packaging Info

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

Packaging configurations for Eagle Brand.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is supplied in an 85 ml unit box, with the National Drug Code (NDC) 43405-011-85.

Uses and Indications

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

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 not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 12 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice to determine the appropriate course of action for this age group.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, tight bandaging is not recommended, as it may compromise circulation and lead to further complications. The product should only be used as directed; any deviation from the specified instructions is contraindicated to ensure safety and efficacy.

Warnings and Precautions

For external use only. It is imperative that this product is not applied to the eyes or mucous membranes, as such exposure may lead to irritation or adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent complications and ensure safety. Care should be taken to avoid tight bandaging of the area where the product is applied, as this may impede proper healing and increase the risk of adverse reactions. The product must be used strictly as directed; any deviation from the recommended usage may result in unforeseen consequences.

Healthcare professionals should advise patients to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure that any underlying issues are appropriately addressed.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Centre should be contacted without delay. Prompt action is essential to mitigate potential health risks associated with ingestion.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes or mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, patients should refrain from tightly bandaging the area where the product is applied and should use it only as directed.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use.

This product should be kept out of reach of children. If swallowed, it is crucial to seek medical assistance or contact a Poison Control Centre immediately.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Eagle Brand.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Centre without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 question.

Postmarketing Experience

Postmarketing experience has revealed that healthcare professionals and patients are encouraged to report any serious side effects or adverse events associated with the use of the product. Reports can be made by calling 1-800-777-6717 or 1-800-645-0769. This information is collected voluntarily and through surveillance programs to enhance the understanding of the product's safety profile in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Centre if the product is swallowed. It is important to emphasize the need to avoid contact with the eyes and mucous membranes, as this could lead to irritation or injury.

Patients should be instructed not to apply the product to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, healthcare providers should inform patients not to bandage the area tightly after application, as this could interfere with the product's effectiveness and increase the risk of side effects.

Finally, it is crucial to remind patients to use the product only as directed and to avoid any other uses that are not specified in the instructions. This will help ensure safety and efficacy in the use of the product.

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 temperatures below 86°F (30°C) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Eagle Brand, 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 Eagle Brand, 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.